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

Model Number IPN915182

Device Problem Break (1069)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

Reported event: the clip was found broken when loaded on applier.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box, lot# 73g2200752.Investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

Qn# (b)(4).The customer returned two loose broken clip halves and one cartridge from one unit of 544230 hemolok ml clips 6/cart 84/box for inve stigation.The returned sample was visually examined with and without magnification.Slight scrape marks were observed on the returned cartridge.One additional hook half was discovered within the returned cartridge.No other defects or anomalies were observed.Visual examination revealed that the broken clips were broken in half at the hinge.Evidence of use in the form of biological material was observed on the returned sample.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area of the clip.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73g2200752 investigation did not show issues related to the complaint.The returned broken clips were broken at the hinge during loading.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.The reported complaint of broken/detached parts - clip - hinge was confirmed based upon the sample received.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Reported event: the clip was found broken when loaded on applier.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16328715
• MDR Text Key: 309139946
• Report Number: 3003898360-2023-00170
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73G2200752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.