BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCLUDE TI LG 24/CART 15/BOX

    MDR report key: 9770760 · Received February 28, 2020

    Report

    Report Number
    3011137372-2020-00084
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 3, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K091060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE FINISHED GOODS DHR WAS REVIEWED. PER THE DHR, LOT NUMBER 7808 OF PRODUCT 60415 VCLUDE TI LG 24/CART 15/BOX WAS MANUFACTURED ON 06FEB2017. A TOTAL OF (B)(4) UNITS WERE MANUFACTURED. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE CUSTOMER RETURNED ONE BOX 60415 VCLUDE TI LG 24/CART 15/BOX FOR INVESTIGATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE PACKAGING LABELS ON THE BOX AND THE CARTRIDGES HAD EXPIRATION DATES OF 2020-02-01. THE SUPPLIER WAS CONSULTED AND THE EXPIRATION DATE OF 2020-02-01 WAS CONFIRMED. THE REPORTED COMPLAINT OF "PRODUCT HAS EXPIRATION DATE 2020-02-01" IS CONFIRMED. A NONCONFORMANCE HAS BEEN INITIATED BY THE GLOBAL LOGISTICS & DISTRIBUTION TEAM TO FURTHER INVESTIGATE THIS ISSUE. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO PREVENT THIS ISSUE FROM RECURRING. REFERENCE FILE ANP20034367 FOR INVESTIGATION PHOTOS. THE REPORTED COMPLAINT OF "PRODUCT HAS EXPIRATION DATE 2020-02-01" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. VISUAL EXAMINATION CONFIRMED THAT THE PACKAGING LABELS ON THE BOX AND THE CARTRIDGES HAD EXPIRATION DATES OF 2020-02-01. A NONCONFORMANCE HAS BEEN INITIATED BY THE GLOBAL LOGISTICS & DISTRIBUTION TEAM TO FURTHER INVESTIGATE THIS ISSUE. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO PREVENT THIS ISSUE FROM RECURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ITEM HAS BEEN SENT TO THE CUSTOMER, BUT THE INCORRECT EXPIRATION IS ON THE LABEL. THE CUSTOMER STATED SHE RECEIVED 10 BOXES OF ITEM, 60415, WITH THE INCORRECT EXPIRATION DATES ON THEM. I CHECKED THE BATCH AND THE STOCK NUMBER, AND THE SYSTEM IS SHOWING THE EXPIRATION DATE IS 02/01/2021. THE CUSTOMER SENT ATTACHMENTS SHOWING THE EXPIRATION DATE IS 02/01/2020. I BELIEVE THERE IS A LABELING ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS ITEM HAS BEEN SENT TO THE CUSTOMER, BUT THE INCORRECT EXPIRATION IS ON THE LABEL. THE CUSTOMER STATED SHE RECEIVED 10 BOXES OF ITEM, 60415, WITH THE INCORRECT EXPIRATION DATES ON THEM. I CHECKED THE BATCH AND THE STOCK NUMBER, AND THE SYSTEM IS SHOWING THE EXPIRATION DATE IS 02/01/2021. THE CUSTOMER SENT ATTACHMENTS SHOWING THE EXPIRATION DATE IS 02/01/2020. I BELIEVE THERE IS A LABELING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235202 VCLUDE TI LG 24/CART 15/BOX CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 7808

    Patients

    Seq Age Sex Outcome Treatment
    1