MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS

Catalog Number 544230

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips (b)(4), lot number 73c1500489 investigation did not show issues related to the complaint.The device sample has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: during use the clips would not close.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).One (1) cartridge of catalog number 544230 hemolok ml clips 6/cart 84/box was received used, opened without original packaging; lot # was not confirmed with samples received.During visual inspection it was observed that cartridge was received with 5 clips placed in slots (a missing clip): clips looked in good condition.Functional inspection: hemolok clips (5) were removed from the slots to review the condition of the clips (posts & hinge); clips undamaged.Clips were loaded manually into the cartridge.Clips were loaded into the clip applier p/n 544171, batch # 04e0800117-020; no quality issues were found.Then clips were closed (closure test) into the appropriate media tubing p/n 06424-66 according to manufacturing procedures qip-0031tec rev.20 & gs-0146tec rev.06; the clips closed correctly.After the closure test the clips were reviewed/verified and the failure mode could not be duplicated.The reported defect "clips not closing" during visual inspection could not be verified.In addition, a functional inspection was performed with clips received, the device worked properly.Corrective action is not required at this time.

Event Description

Alleged event: during use the clips would not close.The patient's condition was reported as unknown.

• Brand Name: HEMOLOK ML CLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5078992
• MDR Text Key: 26256061
• Report Number: 3003898360-2015-00654
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544230
• Device Lot Number: 73C1500489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1