MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI ML 6/CART 120/BOX; CLIP, IMPLANTABLE

Model Number IPN914927

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).From the pictures provided it was confirmed the defect reported by the customer "incomplete seal - sterility compromised".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.The device history review for the product horizon ti ml 6/cart 120/box lot# 73f2200970 investigation did not show issues related to the complaint.Failure mode incomplete seal - sterility compromised could be confirmed with the picture provided.If the complaint samples become available at a later date, this complaint will be updated accordingly.

Event Description

Reported issue: it was detected on receipt that there was an empty cartridge unit and an open cartridge unit.Sterility was breach with the open unit.There was no patient involvement.

Event Description

Reported issue: it was detected on receipt that there was an empty cartridge unit and an open cartridge unit.Sterility was breach with the open unit.There was no patient involvement.

Manufacturer Narrative

(b)(4).The customer returned (b)(4) unit 003200 horizon ti ml 6/cart 120/box for investigation.The cartridge was returned in its original packaging.There were multiple holes in the package.All four corners of the package that surrounds the cartridge had a hole as well as a large hole on the end where the package gets opened.The manufacturing site was contacted as a part of this investigation.There are current controls in place to detect holes in packaging at the manufacturing site.All packages are 100% inspected for holes.If a hole is detected, the package is crushed and discarded.The manufacturing site was unable to replicate this issue as a result of these controls.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.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed.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: HORIZON TI ML 6/CART 120/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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16432985
• MDR Text Key: 310162347
• Report Number: 3003898360-2023-00221
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704696370
• UDI-Public: 24026704696370
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914927
• Device Catalogue Number: 003200
• Device Lot Number: 73F2200970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED