MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOCLIP PLUS TITANIUM LIGATING CLIPS; CLIP, IMPLANTABLE

Model Number	IPN915128
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Operating room has found the outer plastic package of item 533862 with a hole in it.Product defect.
Additional Manufacturer Narrative
(b)(4).The device history review for the product hp ti ml 10/cart 120/box lot# 73c2100951 investigation did not show issues related to the complaint.
Event or Problem Description
Or has found the outer plastic package of item 533862 with a hole in it.Product defect.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 533862 hp ti ml 10/cart 120/box for investigation.The cartridge was returned in its original packaging.There was a hole in the package and it appeared that the package had been slightly crushed.The sample was sent to the manufacturing site for further evaluation.There are current controls in place to detect holes in packaging.It is unlikely that the observed damage was present at the time of manufacturing.It appears that the packaging most likely got broken due to storage/shipping conditions.Reference file (b)(4) for investigation photos and file (b)(4)_tecateinvestigation for the manufacturing site's investigation.A corrective action is not required at this time since storage/shipping conditions appeared to have caused this issue.The reported complaint of "broken package - sterility compromised" was confirmed.The cartridge was returned in its original packaging.There was a hole in the package and it appeared that the package had been slightly crushed.The sample was sent to the manufacturing site for further evaluation.There are current controls in place to detect holes in packaging.It is unlikely that the observed damage was present at the time of manufacturing.It appears that the packaging most likely got broken due to storage/shipping conditions.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOCLIP PLUS TITANIUM LIGATING CLIPS
• Common Device Name: 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: 13952501
• Report Number: 3003898360-2022-00113
• Device Sequence Number: 4524120
• Product Code: FZP
• UDI-Device Identifier: 24026704696226
• UDI-Public: 24026704696226
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Model Number: IPN915128
• Device Catalogue Number: 533862
• Device Lot Number: 73C2100951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown