MAUDE Adverse Event Report: TELEFLEX HP TI MED 10/CART 180/BOX; HEMOCLIPS

Catalog Number 533802

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Death (1802)

Event Date 06/21/2014

Event Type  malfunction  

Event Description

Alleged event: it was reported that clips are detached from vessels after surgery.The report indicated that the pt is deceased.

Manufacturer Narrative

The device history record review could not be conducted since the lot number was not provided.The device sample has not been returned to the mfr at the time of this report.The mfr will continue to monitor and trend related complaints.

• Brand Name: HP TI MED 10/CART 180/BOX
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer Contact: effie jefferson, rn, reg affair ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4197100
• MDR Text Key: 20754450
• Report Number: 3003898360-2014-00818
• Device Sequence Number: 1
• Product Code: MCH
• 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: Other
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 533802
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1