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	12/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
On (b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.
Additional Manufacturer Narrative
(b)(4).Per dhr the product hemolok xl clips 6/cart 84/box lot# 73f2000186 was manufactured on 06/09/2020 a total of (b)(4) pieces.Lot was released on 06/19/2020.Dhr investigation did not show issues related to complaint.During the visual inspection it is observed that the sample does not contain any clips because the user reports having used all the clips, therefore the complaint reported as "broken parts - clips" cannot be confirmed.P/n 544250 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 125 samples were taken from the current production p/n 544240 hemolok l clips 6/cart 84/box lot # 73l2100827, the samples were visually inspected, and during the test issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.Revision of pfmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.The complaint reported as "broken parts - clips" cannot be confirmed.An investigation was carried out for complaint (b)(4) , sample was received with cartridge empty with none of the clips, however, based on issue reported as "broken clip", incoming inspection records for raw material (plastic clip) were reviewed and no defect was found, as well as dhr per manufacturing process (in process loading clips inspection manual and automatic, overstress testing data collection for clip from hemolok assemblies, quality visual inspection record for hemolok assemblies, quality inspection record for packaging).Therefore, the root cause of the problem cannot be determined based on information provided to perform investigation.
Event or Problem Description
(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13154059
• Report Number: 3003898360-2022-00001
• Device Sequence Number: 11781920
• 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,Followup
• Report Date (Section B): 12/31/2021

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: 06/08/2025
• Device Model Number: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: 73F2000186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/18/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown