MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Model Number	IPN055290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related eve.
Event or Problem Description
Clips breaking in half when being loaded.
Event or Problem Description
Clips breaking in half when being loaded.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned 1 unopened representative sample of 51114v vlock ml clip 6/cart 14/box for investigation.The actual sample was not returned.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the packaging was dented, but there was no damage to the cartridge or clips.Functional inspection was performed on the representative sample.A lab inventory clip applier was used.All 6 clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.None of the clips broke during testing.No functional issues were found with the returned clips.It is possible that improper technique or using damaged appliers could cause the clips to break during loading, but the root cause of this complaint could not be confirmed without the actual sample.Additional testing was not required as a part of this complaint investigation.Per the device history review, lot number 9865 of product 51114v vlock ml clip 6/cart 14/box was manufactured on 22nov2019.A total of (b)(4) pieces were manufactured.Dhr investigation did not show issues related to the complaint.A corrective action is not required at this time as there were no issues observed with the representative sample that was returned.The reported complaint of "broken parts - clip - info not provided" could not be confirmed based on the returned sample.One representative sample was returned.The actual sample was not returned.Upon functional inspection, no issues were observed with the returned sample.It is possible that improper technique or using damaged appliers could cause the clips to break during loading, but the root cause of this complaint could not be confirmed without the actual sample.We will continue to monitor and trend on this issue.

• Brand Name: VLOCK ML CLIP 6/CART 14/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11731902
• Report Number: 3011137372-2021-00131
• Device Sequence Number: 11817350
• Product Code: FZP
• UDI-Device Identifier: 24026704666823
• UDI-Public: 24026704666823
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: IPN055290
• Device Catalogue Number: 51114V
• Device Lot Number: 9865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1