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

Catalog Number	004200
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during incoming inspection, it was "found that the printing of the expiration date was abnormal.The expiration date was incorrectly written as '2028-10-04', not '2026-10-04'".No patient involvement.
Event or Problem Description
It was reported that during incoming inspection, it was "found that the printing of the expiration date was abnormal.The expiration date was incorrectly written as '2028-10-04', not '2026-10-04'".No patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "labeling issue - difficult to read" was confirmed based upon the sample received.The customer provided one photo and returned one unit of 004200 horizon ti lg 6/cart 120/box for investigation.The returned unit was an unopened sample in original packaging.The expiration date was incorrectly written as "2028-10-04", rather than "2026-10-04".Dhr investigation did not show issues related to complaint.Actions to address this issue, such as qualifying an improved vision system, were established by the manufacturing site under teleflex quality system.The returned sample was manufactured prior to the implementation of corrective actions.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HORIZON TI LG 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17493813
• Report Number: 3003898360-2023-01212
• Device Sequence Number: 17953611
• Product Code: FZP
• UDI-Device Identifier: 24026704696387
• UDI-Public: 24026704696387
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2026
• Device Catalogue Number: 004200
• Device Lot Number: 73K2100125
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown