MAUDE Adverse Event Report: COVIDIEN PALINDROME SAPPHIRE 28/45KT VT; DIALYSIS CATHETER

Model Number 8888145049C

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 08/28/2013

Event Type  malfunction  

Event Description

It was reported to covidien that a customer had an issue with a dialysis catheter.The customer observed leakage from a crack in catheter (blood leakage).The catheter was implanted in the left internal jugular vein.The catheter was pulled and replaced with a new one.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: PALINDROME SAPPHIRE 28/45KT VT
• 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 ; 15 hampshire st; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3716640
• MDR Text Key: 4253561
• Report Number: 1317749-2014-00113
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145049C
• Device Catalogue Number: 8888145049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1