MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Catalog Number 544230

Device Problems Break (1069); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73e1800442 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that either the clip fell from the applier or the clip broke during insertion on the applier.

Event Description

It was reported that either the clip fell from the applier or the clip broke during insertion on the applier.

Manufacturer Narrative

Qn#(b)(4).The customer returned four representative samples of 544230 hemolok ml clips 6/cart 84/box for investigation.These representative samples are for this tc and tc 1900065793.The actual sample was not returned.The representative samples were returned closed in their original packaging.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the clips appear typical.No defects or anomalies were observed.The clip applier was not returned.Functional inspection was performed on the returned representative samples.A lab inventory clip applier was used.All six clips in the first cartridge that was tested were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.This was repeated for the three remaining cartridges with the same results.No clips fell from the applier or broke during testing.No functional issues were found with the returned clips.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were only representative samples that were returned and there were no functional issues found with the returned samples.The reported complaint of "broken clips" could not be confirmed since the actual sample was not returned.Four representative samples were returned in place of the actual sample that resulted in the complaint issue.Upon functional inspection, no problems were found as all clips were able to be properly loaded into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.The probable cause of this issue could not be determined without the actual sample.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8286617
• MDR Text Key: 134446688
• Report Number: 3003898360-2019-00140
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 544230
• Device Lot Number: 73E1800442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1