Compat Nasogastric Feeding Tube 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Nestle HealthCare Nutrition 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-07-26
  • 사례 출판 날짜
    2013-07-26
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: nestle compat nasogastric feeding tube it has come to our attention that the medical device manufacturer, nestle healthcare nutrition, inc. has initiated a medical device field safety corrective action concerning compat nasogastric feeding tubes with universal “y” adapter and stretch-lok strap (compat ng tubes). the affected models are compat nasogastric feeding tube 8fr, 10fr and 12 fr. the affected lots are: 08211z, 14212u, 35411h, 02412k, 14611p, 01413g, 08712w, 21512y for compat nasogastric feeding tube 8fr; 08712d , 05312n , 08111m, 10211e, 13712w, 21512f, 01613g for compat nasogastric feeding tube 10fr; and 05912f , 01211av, 04111p, 04111v, 05812f, 21512g, 01513n, 06313n, 23412bv, 34712v, 35411u, 04111d for compat nasogastric feeding tube 12fr. according to the manufacturer, this recall has been initiated due to the fact that some of the compat ng tubes have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label. the manufacturer assures customers that all compat ng tubes have gone through the sterilization process and there have been no complaints associated with the recalled product. however, the manufacturer is recalling the affected products because the sterility claim on the label cannot be 100% certified and verified. patient safety risk is considered negligible for the following reasons: the gastrointestinal tract normally contains many different bacteria species; nasogastric tubes become non-sterile as soon as they are placed through the nasal cavity; if brought into a sterile environment such as an operating room because of the “ sterile” labeling, standard operating procedures in those environments would minimize the chance of contamination via gloves or a similar mechanism. other products on the market with the same intended use are sold non-sterile. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 july 2013 revised on 8 august 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Nestle Compat Nasogastric Feeding Tube
  • Manufacturer

Manufacturer