MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI SMALL RED 25 POUCHES WITH 24; CLIP, IMPLANTABLE

Model Number	IPN002004
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The reported complaint was not able to be fully confirmed by the photo.The customer also returned one unit of 001205 horizon ti small red 25 pouches with 24 for investigation.The returned unit was an unopened sample in its original packaging.The sample was visually examined with and without magnification.Visual inspection revealed that the packaging was punctured, and that the sterility of the packaging was compromised.It was observed that the damage to the packaging lined up with the raised portions of the cartridge.The damage appeared to have resulted from the horizon cartridge puncturing the packaging from the inside to the outside.No defects or anomalies were observed on the cartridges inside the packaging.A device history record review was performed and no relevant findings were identified.Packaging engineering was consulted as a part of this investigation.Per packaging engineering, the damage indicates a potential storage/shipping issue, but the root cause could not be conclusively determined from the returned sample.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
The complaint is reported as: "(b)(6) 2023, cartridge was found broken during incoming inspection." no patient involvement.Upon inspection of the returned device at the investigation site, it was discovered that the package was actually punctured and the sterility was compromised.

• Brand Name: HORIZON TI SMALL RED 25 POUCHES WITH 24
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17070784
• Report Number: 3003898360-2023-00892
• Device Sequence Number: 6105139
• Product Code: FZP
• UDI-Device Identifier: 34026704410232
• UDI-Public: 34026704410232
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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?: Yes
• Device Model Number: IPN002004
• Device Catalogue Number: 001205
• Device Lot Number: 73C2200787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown