MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 25 POUCHES WITH 24 CLIPS; CLIP, IMPLANTABLE

Model Number	IPN914926
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was trying to clip abdominal vessels in patient, clips were applied but noted to be slipping on the vessels; not holding and sliding up and down.Appliers checked and met teleflex applier care standard.Clips removed from sterile field and tested - there appears to be small gap at the bottom of the clip when it is closed and this is causing the clip to slide.Several clips were tested and observed to be doing the same thing.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Surgeon was trying to clip abdominal vessels in patient, clips were applied but noted to be slipping on the vessels; not holding and sliding up and down.Appliers checked and met teleflex applier care standard.Clips removed from sterile field and tested - there appears to be small gap at the bottom of the clip when it is closed and this is causing the clip to slide.Several clips were tested and observed to be doing the same thing.
Additional Manufacturer Narrative
Qn#: (b)(4).Per dhr the product horizon ti med 25 pouches with 24 clips lot# 73e1900764 was manufactured on 05/28/2019 a total of (b)(4) pieces.Lot was released on 06/06/2019.Dhr investigation did not show issues related to complaint.Revision of (b)(4) rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.
Event or Problem Description
Surgeon was trying to clip abdominal vessels in patient, clips were applied but noted to be slipping on the vessels; not holding and sliding up and down.Appliers checked and met teleflex applier care standard.Clips removed from sterile field and tested - there appears to be small gap at the bottom of the clip when it is closed and this is causing the clip to slide.Several clips were tested and observed to be doing the same thing.

• Brand Name: HORIZON TI MED 25 POUCHES WITH 24 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: 13584298
• Report Number: 3003898360-2022-00056
• Device Sequence Number: 5731245
• Product Code: FZP
• UDI-Device Identifier: 34026704696315
• UDI-Public: 34026704696315
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 05/27/2024
• Device Model Number: IPN914926
• Device Catalogue Number: 002204
• Device Lot Number: 73E1900764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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