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

Catalog Number	002200
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the inspection, it was found that 1 cartridge was unsealed, with no signs of adhesive or any indication that it had been sealed".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned one unit of 002200 horizon ti ml 6/cart 180/box for investigation.The device was returned open without the packaging.Evidence of use in the form of biological material was observed on the cartridge.As a result, the reported complaint could not be fully confirmed and conclusively linked to a manufacturing issue.Six correctly seated clips were returned in the cartridge.The reported complaint of "packaging damage - sterility compromised" could not be fully confirmed and conclusively linked to a manufacturing issue.A dhr review was performed with no evidence to suggest a manufacturing related cause.Evidence of use in the form of biological material was observed on the cartridge.As a result, the reported complaint could not be fully confirmed and conclusively linked to a manufacturing issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during the inspection, it was found that 1 cartridge was unsealed, with no signs of adhesive or any indication that it had been sealed".No patient involvement.

• Brand Name: WECK HORIZON TI MED 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22152953
• Report Number: 3003898360-2025-00472
• Device Sequence Number: 13141650
• Product Code: FZP
• UDI-Device Identifier: 04026704410248
• UDI-Public: (01)04026704410248(11)240508(17)290506(10)73E2400276(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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 Catalogue Number: 002200
• Device Lot Number: 73E2400276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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