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

Model Number IPN028170

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2023

Event Type  malfunction  

Event 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.

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
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16868164
• MDR Text Key: 314626055
• Report Number: 3003898360-2023-00776
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704624752
• UDI-Public: 34026704624752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN028170
• Device Catalogue Number: 001201
• Device Lot Number: 73D2100953
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1