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 Patient Involvement (2645)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the hemolok clips found to be broken or incompleteness while in brand-new condition.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73f1800013 was manufactured on 06/04/2018 a total of 14,000 pieces.Lot was released on 06/08/2018.Dhr investigation did not show issues related to complaint.The customer returned one half of a clip from unit 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was not returned.The clip was visually examined with and without magnification.Visual examination of the clip revealed that the clip exhibited a staggered break where it was broken in the middle of the inner hinge but also broken at the outer hinge towards the side of the clip with the pierced bosses.Only the hook half of the clip was returned.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu 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 of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.Half of a clip was returned loose.The clip exhibited a staggered break where it was broken in the middle of the inner hinge and was broken at the outer hinge towards the side of the clip with the pierced bosses.Only the hook half of the clip was returned.It could not be determined exactly how or what caused the returned clip to break at the hinge.A capa has been previously opened to further investigate issues related to clip breakages.

Event Description

It was reported that the hemolok clips found to be broken or incompleteness while in brand-new condition.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8852159
• MDR Text Key: 153011236
• Report Number: 3003898360-2019-00978
• 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,u
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Catalogue Number: 544230
• Device Lot Number: 73F1800013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1