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

Catalog Number	51114V
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor failed to detach(separate) the holded blood vessel with 51114v and its applier.This resulted in tearing of the blood vessel during the isolation process.After medical interventio0n by bleeding control through electric caute.It is confirmed that patient is fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor failed to detach(separate) the holded blood vessel with 51114v and its applier.This resulted in tearing of the blood vessel during the isolation process.After medical interventio0n by bleeding control through electric caute.It is confirmed that patient is fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing on the actual sample could not be performed as the actual sample was not returned for analysis.A rep resentative was received at the manufacturing site for evaluation.A device history record review identified no relevant findings and it was concluded that the batch was manufactured and released according to specified process parameters.It was determined upon co mpletion of evaluation that no rmi production practices could have contributed to the issue.The root cause was undetermined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: VLOCK ML CLIP 6/CART 14/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17965816
• Report Number: 3011137372-2023-00229
• Device Sequence Number: 17783398
• Product Code: FZP
• UDI-Device Identifier: 24026704666823
• UDI-Public: 24026704666823
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2025
• Device Catalogue Number: 51114V
• Device Lot Number: 228025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown