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

Catalog Number	544250
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "package was found broken during inspection".No patient involvement.
Event or Problem Description
It was reported that "package was found broken during inspection".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.A device history record review was performed, and no relevant findings were identified.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HEMOLOK XL CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18476989
• Report Number: 3003898360-2024-00094
• Device Sequence Number: 15101773
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 06/08/2025
• Device Catalogue Number: 544250
• Device Lot Number: 73F2000186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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