MAUDE Adverse Event Report: COVIDIEN UNKNOWN DY; PALINDROME CATHETER

Model Number UNKNOWN DY

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer states that there was a catheter failure, however no record of the failure mode.The catheter was pulled and replaced with a new one.No additional information provided by the customer.

Manufacturer Narrative

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

• Brand Name: UNKNOWN DY
• Type of Device: PALINDROME 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: 3843570
• MDR Text Key: 4684941
• Report Number: 1317749-2014-00075
• Device Sequence Number: 1
• Product Code: MSD
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2014

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: UNKNOWN DY
• Device Catalogue Number: UNKNOWN DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1