MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI SMALL RED 6/CART 180/BOX; CLIP, IMPLANTABLE

Model Number	IPN028170
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that during prior to use in the clinical setting "when staff tries to take the clips using the clip applier, pieces of the plastic are attached to it and they have seen it on the surgical site".Additional information received from the customer states that they are "primarily finding on sterile field and having to break down mid procedure due to the white plastic from the mechanism that holds the clips in place prior to loading".Per the customer, there is no patient involvement as the particulates are found prior to patient use when the surgeon is ready to utilize the applier on the patient.
Additional Manufacturer Narrative
(b)(4).Per dhr the product horizon ti small red 6/cart 180/box lot# 73d2100953 was manufactured on 04/30/2021 a total of (b)(4) pieces.Lot was released on 05/17/2021.Dhr investigation did not show issues related to complaint.

• Brand Name: HORIZON TI SMALL RED 6/CART 180/BOX
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16868164
• Report Number: 3003898360-2023-00776
• Device Sequence Number: 5957890
• Product Code: FZP
• UDI-Device Identifier: 34026704624752
• UDI-Public: 34026704624752
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2026
• Device Model Number: IPN028170
• Device Catalogue Number: 001201
• Device Lot Number: 73D2100953
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown