MAUDE Adverse Event Report: COVIDIEN PALINDROME 28/45 KIT W/SLOT; DIALYSIS CATHETER

Model Number 8888145016

Device Problems Air Leak (1008); Device Inoperable (1663); Torn Material (3024)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states that the sealing cap has a tear and air is going in.This issue was noticed during pt use.The catheter was pulled and replaced with a new one.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: PALINDROME 28/45 KIT W/SLOT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer Contact: lawrence rock ; 5439 state route 40; argyle, NY 12809 ; 5082616625
• MDR Report Key: 3970247
• MDR Text Key: 18067379
• Report Number: 1317749-2014-00207
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 04/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 67