MAUDE Adverse Event Report: TELEFLEX WECK HEMOLOK L CLIPS 6/CART 84/BOX

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

Alleged issue: the clips did not lock on the arteries or the renal veins.There were no consequences to the pt.

Manufacturer Narrative

A device history record (dhr) review did not show issues related to complaint.Device sample has been returned to the mfr; however, the investigation has not been submitted at the time of this report.

• Brand Name: WECK HEMOLOK L CLIPS 6/CART 84/BOX
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio
• Manufacturer Contact: doris sturgis, specialist ; po box 12600; rtp, NC 27709 ; 9194334953
• MDR Report Key: 4383891
• MDR Text Key: 5265044
• Report Number: 3003898360-2014-00963
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 544240
• Device Lot Number: 73D1400390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1