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

Catalog Number 001201

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product horizon ti small red 6/cart 180/box lot# 73d2100036 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

On (b)(6) 2021, the package was found broken incoming inspection.Additional information: the customer described that the packaging seal was broken , and no photos were provided.This incident occurred during sample inspection.The physical object has been sent; please directly check the physical object at that time.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 12934247
• MDR Text Key: 283303079
• Report Number: 3003898360-2021-01097
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001201
• Device Lot Number: 73D2100036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1