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

Model Number	IPN915186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).A visual, dimensional nor functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per dhr the product hemolok xl clips 6/cart 84/box lot# 73c1900100 investigation did not show issues related to the complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available later, this complaint will be updated accordingly.
Event or Problem Description
On (b)(6)2022, clip was found broken during using on the patient.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15249710
• Report Number: 3003898360-2022-00409
• Device Sequence Number: 12182967
• Product Code: FZP
• UDI-Device Identifier: 24026704695953
• UDI-Public: 24026704695953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 03/04/2024
• Device Model Number: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: 73C1900100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown