MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC COVIDIEN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884752505E

Device Problem Connection Problem (2900)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Patient to be discharged with naso-jejunal feeding tube and follow-up.The feeding tube would not connect to the feeding pump.After multiple attempts, the physician decided to remove the tube and reinsert a new tube.Original packing was discarded as item was placed at the beginning of the patient's visit.Any information related to the product was obtained from a new package for this item.

• Brand Name: COVIDIEN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16277182
• MDR Text Key: 308590501
• Report Number: 16277182
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884752505E
• Device Catalogue Number: 8884752505E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Date Report to Manufacturer: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA