MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 3/CART 42/BOX; CLIP, IMPLANTABLE

Catalog Number 544243

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok l clips 3/cart 42/box lot# 73c2100760 investigation did not show issues related to the complaint.

Event Description

(b)(6)2022 , the clip was found broke prior to the patient.

Manufacturer Narrative

(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.P/n 544243 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 544250 hemolok xl clips 6/cart 84/box lot # 73h2200112, 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.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

On 10 aug 2022, the clip was found broken prior to the patient.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/BOX
• Type of Device: 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: 15363193
• MDR Text Key: 305454515
• Report Number: 3003898360-2022-00443
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544243
• Device Lot Number: 73C2100760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1