BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON TI LG 6/CART 120/BOX

    MDR report key: 17493813 · Received August 9, 2023

    Report

    Report Number
    3003898360-2023-01212
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 19, 2023
    Report Date
    July 21, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    UDI-DI
    24026704696387
    PMA / PMN Number
    K132658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689567 HORIZON TI LG 6/CART 120/BOX CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 73K2100125 24026704696387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.