MAUDE Adverse Event Report: COVIDIEN HD CATHETER REPAIR KIT; DIALYSIS CATHETER

Model Number 8888200001

Device Problem Crack (1135)

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

Event Date 12/09/2013

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2013 that a customer had an issue with a dialysis catheter.The customer states that connector has a crack after 17 days use- without pressure force.Treatment of product with octemisept.The product tested prior to use.

Manufacturer Narrative

Submit date: (b)(4) 2014.

• Brand Name: HD CATHETER REPAIR KIT
• 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 street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3772809
• MDR Text Key: 18929191
• Report Number: 1317749-2014-00009
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/09/2013

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: 8888200001
• Device Catalogue Number: 8888200001
• Device Lot Number: 229101X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1