MAUDE Adverse Event Report: TELEFLEX HEMOLOK L CLIPS 5/CART 84/BOX; HEMOCLIPS

Catalog Number 544240

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

Alleged event: the cartridge packaging was found open before use.The patient's condition was reported as fine.

Manufacturer Narrative

The device history record (dhr) review the product hemolok l clips 5/cart 84/box, lot# 01f1300154 was manufactured on june 12, 2013 a total of (b)(4) pieces.Lot was released on june 20, 2013.Dhr investigation did not show issues related to complaint.The device sample has been returned to the manufacturer but the investigation report is not available at the time of this report.The manufacturer will continue to monitor and trend related complaints.

• Brand Name: HEMOLOK L CLIPS 5/CART 84/BOX
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer (Section G): PROLONGACION MISION EUSEBIO
• Manufacturer Contact: effie jefferson, fn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4029905
• MDR Text Key: 4729133
• Report Number: 3003898360-2014-00473
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• 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: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 544240
• Device Lot Number: 01F1300154
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2014
• Date Device Manufactured: 06/13/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1