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 12/13/2021

Event Type  malfunction  

Event Description

A clip got broken when a nurse loaded it to the applier during a surgery.Therefore, a new cartridge was opened instead.No patient injury reported.

Manufacturer Narrative

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

Event Description

A clip got broken when a nurse loaded it to the applier during a surgery.Therefore, a new cartridge was opened instead.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).There are two potential lot numbers for the defective sample: 73d2100948 or 73f2100690.A dhr review was performed for both lot numbers.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73d2100948 was manufactured on 04/30/2021 a total of (b)(4).Lot was released on 05/14/2021.Dhr investigation did not show issues related to complaint.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73f2100690 was manufactured on 06/22/2021 a total of (b)(4).Lot was released on 07/07/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.Two lid stocks from two different lot numbers were returned.Additionally, the hook half of a clip was returned loose and was broken in half at the hinge.The cartridge was visually examined with and without magnification.The cartridge was returned with 3 intact clips and one half of a clip remaining in it.The broken clip half was the pierced boss half that and was broken in half at the hinge.The cartridge was scraped on the slot with the broken clip.The sample appears used as biological material was present on the device.The clips breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Functional inspection was performed on the intact clips remaining in the cartridge.A lab inventory clip applier was used.All 3 clips were able to properly load into the applier and were successfully applied to over-stressed surgical tubing.No issues were observed with the intact clips.The ifu for this product, l02425, 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." a clip was returned broken in half at the hinge during loading.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.The cartridge was returned with three intact clips and one broken clip half that was broken in half at the hinge during loading.The other half of the broken clip was returned loose.The clips breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12983932
• MDR Text Key: 282111611
• Report Number: 3003898360-2021-01121
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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