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 Patient Involvement (2645)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok l clips 3/cart 42/box lot# 73c1900098 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that (b)(6) 2020, in (b)(6), the boss of the clip was found broken prior to the patient after being uploaded for the operation of appendicitis by a doctor in (b)(6).

Event Description

It was reported that (b)(6) 2020, in (b)(6) hospital of (b)(6), the boss of the clip was found broken prior to the patient after being uploaded for the operation of appendicitis by a doctor in (b)(6).

Manufacturer Narrative

Qn# (b)(4).Per dhr the product hemolok l clips 3/cart 42/box lot# 73c1900098 was manufactured on 03/05/2019.A total of (b)(4) pieces.Lot was released on 03/15/2019.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544243 hemolok l clips 3/cart 42/box for investigation.One loose clip was also returned.The cartridge and clip were visually examined with and without magnification.Visual examination revealed that the clip was returned with the pierced leg-tip and pierced bosses broken off.The cartridge contained one of the broken pierced bosses and no intact clips remaining in it.R & d was consulted.The boss break was found to be a result of porosity in the boss area that was likely caused by trapped gas or air in the material, from insufficient mold cleaning during a long production run.The root cause is teleflex's lack of specification around boss requirements leading to insufficient controls of porosity/run times at the supplier.A capa has been previously opened to further investigate issues related to clip breakages.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu states the following: "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge.Gently press the applier over the clip until there is an audible click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily." "remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.It may be necessary to hold the cartridge to allow the clip to be removed." "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 clip was returned with the pierced bosses broken off.The root cause is teleflex's lack of specification around boss requirements leading to insufficient controls of porosity/run times at the supplier.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken/detached parts - clip - boss" was confirmed based upon the sample received.One loose clip was returned with the pierced bosses broken off.The boss break was found to be a result of porosity in the boss area that was likely caused by trapped gas or air in the material, from insufficient mold cleaning during a long production run.The root cause is teleflex's lack of specification around boss requirements leading to insufficient controls of porosity/run times at the supplier.A capa has been previously opened to further investigate issues related to clip breakages.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9866415
• MDR Text Key: 184620052
• Report Number: 3003898360-2020-00286
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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 Expiration Date: 03/04/2024
• Device Catalogue Number: 544243
• Device Lot Number: 73C1900098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1