MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS; HEMOCLIPS

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 event: it was reported that during use on a pt the clips did not close.The pt's condition was reported as fine.

Manufacturer Narrative

Qn# (b)(4).The device history record review for the prod hemolok l clips 6/cart 84/box, lot #73d1400390 investigation did not show issues related to the complaint.The mfr will continue to monitor and trend related complaints.

• Brand Name: HEMOLOK L CLIPS
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4432449
• MDR Text Key: 5376940
• Report Number: 3003898360-2015-00014
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/23/2019
• Device Catalogue Number: 544240
• Device Lot Number: 73D1400390
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1