MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 888119369

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Stylet inside package wouldn't advance into dialysis catheter.We were finally able to get one advanced to change the catheter.Stylet wouldn't advance in either port.Fda safety report id# (b)(4).

• Brand Name: PALINDROME DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 10338096
• MDR Text Key: 201043806
• Report Number: MW5095768
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/10/2022
• Device Catalogue Number: 888119369
• Device Lot Number: 1935100070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1