Events

Device Recall PowerPICC catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79070
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0536-2018
  • 사례 시작날짜
    2017-12-28
  • 사례 출판 날짜
    2018-02-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161273
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    peripherally inserted central catheter - Product Code LJS
  • 원인
    Possible leaks on the 3 fr. single lumen and 4 fr. dual lumen powerpicc catheters at the luer hub extension leg junction.
  • 조치
    Customers were notified via letter on approximately 12/28/2017. Instructions include a reminder that if additional extension sets are attached to the luers of the catheters, they should be appropriately secured as per hospital recommended securement protocol, to refrain from having unsupported extension sets that could put stress on the luer extension leg junction of the catheter, and to notify customers if the product was further distributed. Also, the notification contained a statement that Bard Access is in the process of updating their Instructions for Use to include a statement regarding the importance of properly securing additional extension sets per hospital recommended securement protocol. On 04/11/2018, the recall was expanded and customers were notified via letter, which explained that the previous recall has been expanded to involve return of affected product as well as include product distributed from February 2017 through March 2018. Instructions included to examine inventory for affected product, quarantine and immediately discontinue distribution of the product, complete and return the Business Recall Response Form, arrange for the return of affected product, and notify customers if the product has been further distributed. For distributors, Bard Access Systems requested a customer list so that they could notify their customers.

Device

Device Recall PowerPICC catheter
  • 모델명 / 제조번호(시리얼번호)
    Product Code (Lot/Serial No.): S1274108D (REBN2334), S9274108D (REBN2336), S3274108PD (REBP1471), S3274335 (REBP1580), S3274355 (REBP1581), S3274355P (REBP1582), S3274335P (REBP1583), S1274108PD (REBP1971), S1274108 (REBQ1883), S3274355 (REBQ1884), S3274335 (REBQ1885), S3274108D (REBQ1886), S1274108D (REBQ1887), S9274108PD (REBQ1888), S0274108PD (REBQ1889), S3274335P (REBQ1890), S1274118 (REBQ1891), S9274108D (REBQ1892), S1274108D (REBR0160), S1274108D (REBN1883), S1173108D (REBN2329), S9173108D (REBN2332), S1274108PD (REBN2378), S9274108PD (REBN2379), S1173108PD (REBP0948), S3173335 (REBP0949), S3173355 (REBP0950), S9173108PD (REBP1020), s3173355p (REBP1023), S3173335P (REBP1024), S3274108D (REBQ1276), S1173108 (REBQ1882), S1173108 (REBQ2473), S1173108D (REBQ2474), S9173108D (REBQ2475), S1173108PD (REBQ2479), S0173108PD (REBR1399), S1173108PD (REBS0167), S3274108D (REBQ2476), S3173108PD (REBQ2480), S3173355 (REBQ2586), S3173335 (REBQ2587), s3173355p (REBQ2590), s3173108d (REBQ2592), S1173108PD (REBR1398), S0173108PD (REBS2081), S1274108D , REBS0062), S1274108D (REBS1035), S1274108D (REBS1567), S1274108D (REBR1347), S9274108D (REBQ2477), S3274355P (REBS0026), S3274335P (REBS0534), S3274335 (REBS0574), S3274355P (REBS1557), S3274355P (REBS2011), S3274355P (REBS2550), S1274108D (REBS2562), S1274118 (REBT0078), s1274108pd (REBT0146), S1274108PD (REBT0146), S3274355P (REBT0168), S3274355P (REBT0204), CK000765 (REBT0255), S1274108 (REBT0682), S0274108PD (REBT0697), S9274108D (REBT0754), S1274108D (REBT0755), S1274108PD (REBT0757), S3274335 (REBT0805), CK000765 (REBT0843), S9274108PD (REBT1446), S9274108 (REBT1885), CK000767 (REBT1889), S3274108PD (REBT2364), S9274108D (REBU0059), CK000767 (REBW1216), S3274355 (REBR1259), S3173355 (REBR1261), S1274108PD (REBR1345), S3274108PD (REBR1401), S1274108D (REBS0781), S3274355P (REBS0843), S1274108D (REBS1033), S1274108D (REBS2070), CK000759 (REBS2133), S3173355P (REBT0101), S3173335P (REBT0116), S3173355P (REBT0737), S3274335 (REBT1585), S1274108D (REBT1602), S3274355 (REBT1802), S3274108 (REBT1884), ck000770 (REBU0664), S9274108D (REBU0691), S1173108 (REBU1584), S9274108D (REBU1639), S1173108D (REBV0536), S1274108D (REBW0268), S3173108D (REBR1014), S1173108D (REBS1988), S3173108D (REBT0147), S9173108PD (REBT0234), S1173108D (REBT0240), S1173108D (REBT1398), S3173355P (REBT1801), S3173108 (REBT1882), S9173108 (REBT1883), S3173355P (REBT1948), S3173355P (REBU0082), S1173108D (REBU0293), S1173108D (REBU0690), S3173355P (REBU0714), S0173108PD (REBU1224), S3173355P (REBU1265), s9173108pd (REBU2255), S3173335P (REBV0052), S3173118 (REBV1102), S9173118 (REBV1103), S1173108PD (REBW1843), S3173108PD (REBX1664), s1173108 (REBT0688), S1274108D (REBU0296), S1274108D (REBU0765), S1274108 (REBU1047), S1274108D (REBU1271), S9173108D (REBU1640), S1274108PD (REBW0728), s3173355 (REBW1532), S1173108 (REBX1560), S1173108PD (REBX1663), S3173118 (REBY0008), S1173108D (REBY0782), S1173108PD (REBY0832), S0173108PD (REBY1316), S1173108 (REBY1472), S1173108D (REBY2516), CK000283A (REBV1203), S3173108PD (REBS0171), S3274108PD (REBT0233), S9274108PD (REBT1340), S3274108PD (REBT1403), S1274108 (REBT1846), s1274108 (REBT2073), S9274118 (REBU0001), S9274118 (REBU0002), S3274355 (REBU0083), S3274108D (REBU0297), S9274108PD (REBU0694), S3274355 (REBU0734), S3274355 (REBV0533), S3274118 (REBV1104), CK000114A (REBV2151), S1274108PD (REBV2327), S1274108D (REBW1840), S1274108D (REBX0325), CK000770 (REBX0460), S1274108D (REBX1581), CK000759 (REBX2038), S1274108D (REBX2436), S1274108D (REBX0326), S1274108PD (REBY0780), S1274108D (REBY0835), S1274108 (REBY1004), S1274108D (REBZ0814), CK000114A (REBZ1268), S1274108D (REBV1690), CK000770 (REBV2233), S1274108D (REBV2326), S1274108D (REBW0782), CK000759 (REBW1228), S1274108D (REBW1841), S1274108D (REBW1988), CK000767 (REBX0441), CK000759 (REBX0457), S1274108PD (REBX1122), S1274108D (REBX1240), S1274108PD (REBY1239), S1173108D (REBZ0958), S1173108PD (REBZ1627), S1274108D (RECN0085), S1274108PD (RECN0939), S1274108 (RECN1068), CK000114A (RECQ0041), S3173335 (REBY1941), S1173108D (REBY1982), S9173108PD (REBZ0816), S1173108D (REBZ0838), S1173108PD (REBZ0840), S3173108PD (REBZ0960), S1173108PD (RECN0088), S1173108D , RECN1199), s1173108pd (RECN1200), S3173108PD (RECN1406), S1173108D (RECN2175), S1173108PD (RECN2177), S0173108PD (RECN2678), S1173108D (RECP0357), S1173108PD (RECP0594), S1173108 (RECP1895), S3173355 (RECP2311), S1274108D (REBY0518), S3274108D (REBY0834), S1274108PD (REBY2518), S1173108PD (REBY2740), S9274108PD (REBZ0815), s1274108pd (REBZ1718), S1274108PD , RECN0027), S1274108PD (RECN2563), S3274108D (REBX2246), S3274335 (REBY0879), S1274108D (REBY2013), S3274335 (RECN0888), S1274108D (RECN0938), S1274108D (RECN2573), S3274108D (RECN2679), S9274108D (RECP0358), S1274108D (RECP0590), S3274355 (RECP0846), S1274108PD (RECP2482), S3274108D (RECQ0417), S3274108D (REBY2517), S1274108D (REBY2739), S3274355 (REBZ0494), S3274335 (REBZ0681), S3274108D (REBZ0839), S1274108D (REBZ0885), S1274108D (REBZ1625), S1274108 (REBZ1678), S1274108D (RECN1381), S1274108D (RECN2461), S3274108D (RECP0591), S9274108PD (RECP1511), S3274355 (REBZ1826), S3274108D (RECN0023), S9274108D (RECN0084), S9274108D (RECN1403), S1173108 (REBY1170)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution US nationwide.
  • 제품 설명
    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
  • Manufacturer
    Bard Access Systems Inc.

Manufacturer

Bard Access Systems Inc.
  • 제조사 주소
    Bard Access Systems Inc., 605 N 5600 W, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA