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

Model Number	IPN914927
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor detected in receiving 1 unit with damaged cartridge.
Additional Manufacturer Narrative
Qn# (b)(4).The device history review for the product horizon ti ml 6/cart 120/box lot# 73m2100251 investigation did not show issues related to the complaint.
Event or Problem Description
The distributor detected in receiving 1 unit with damaged cartridge.
Additional Manufacturer Narrative
Qn#(b)(4) per dhr the product horizon ti ml 6/cart 120/box lot# 73m2100251 was manufactured on 12/13/2021 a total of (b)(4)pieces.Lot was released on 01/11/2022.Dhr investigation did not show issues related to complaint.The customer provided two photos for analysis; reference pic1_tc# 1900094048 for the customer supplied photos.The complaint of broken package - sterility compromised was able to be confirmed by the photo.The customer returned one sample of 003200 horizon ti ml 6/cart 120/box for investigation.The returned sample was unopened in its original packaging.Visual inspection revealed a crack along one corner of the packaging, including the sterile seal.The reported defect was confirmed.All horizon clips are subjected to 100% inspection for proper packaging, as well as qc inspection based on aql.It is unlikely that this type of damage was present when the sample left the manufacturing facility.Manufacturing was contacted as part of this complaint investigation.Manufacturing stated that the mark/bend present on the sterile sealing was characteristic of a shipping issue.Therefore, the packaging appears to have been damaged during shipping/handling.A corrective action is not required at this time as the packaging appears to have been damaged during shipping/handling.The reported complaint of "broken package - sterility compromised" was confirmed based upon the sample received.Visual inspection revealed a crack along one corner of the packaging, including the sterile seal.All horizon clips are 100% inspected at manufacturing.It is unlikely that this type of damage was present when the sample left the manufacturing facility.Therefore, the packaging appears to have been damaged during shipping/handling after it left the control of teleflex.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HORIZON TI ML 6/CART 120/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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14980160
• Report Number: 3003898360-2022-00262
• Device Sequence Number: 12020695
• Product Code: FZP
• UDI-Device Identifier: 24026704696370
• UDI-Public: 24026704696370
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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 Model Number: IPN914927
• Device Catalogue Number: 003200
• Device Lot Number: 73M2100251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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