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

Catalog Number 544230

Device Problem Break (1069)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as the sample is pending to be returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 20 samples were taken from the current production p/n 544230 hemolok ml clips 6/cart 84/box lot# 73b2400154, the samples were functionally inspected, and during the inspection issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "a clip got broken during a surgery.Therefore, a new cartridge was used to complete the procedure.No injury to the patient occurred." patient's current condition reoported as "fine".

Event Description

It was reported "a clip got broken during a surgery.Therefore, a new cartridge was used to complete the procedure.No injury to the patient occurred." patient's current condition reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one cartridge of 544230 hemolok ml clips 6/cart 84/box for investigation.Visual examination revealed that there was one intact clip and one broken clip in the cartridge.The broken clip was broken in half at the hinge.Functional inspection was performed on the returned intact clip.The intact clip was able to load properly into the jaws of a lab inventory applier and was successfully applied to over-stressed tubing.No functional issues were found with the returned intact clip.A device history record review was performed and no relevant findings were identified.The ifu for this product states , "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." the reported complaint was confirmed based upon the sample received.The broken clip was returned broken at the hinge.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area on the pierce leg side of the hinge.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.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18841443
• MDR Text Key: 337013159
• Report Number: 3003898360-2024-00280
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 544230
• Device Lot Number: 73G2301070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1