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
Tube tracheostomy and tube cuff - Product Code JOH
원인
Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.
조치
Consignees were sent an "Urgent Device Alert" letter dated 01/14/2009, by mail via Federal Express overnight delivery and instructed to evaluate any of the affected lot numbers of tracheostomy tubes prior to placement into a patient's stoma. If either the obturator or the desired sterile suction catheter does not fit properly into the tube, the tube must not be inserted into the patient. Further instructions are available at Nellcor Technical Services by calling 1-800-635-5267, option 3, then option 1. New product was expected by mid February, 2009, to address the issue.
Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. || The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.