BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9671260 · Received February 5, 2020

    Report

    Report Number
    1036844-2020-00043
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    July 5, 2019
    Report Date
    January 31, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH A POTENTIALLY RELEVANT FINDING. A NONCONFORMANCE WAS INITIATED ONLY AS A GENERAL NC TO TEMPORARILY ALLOW CERTAIN FINISHED GOOD PART NUMBERS TO BE PACKAGED WITH ADDITIONAL GAUZE IN ORDER TO BETTER SECURE MEDICATION AMPULES IN THE INNER TRAY. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH A POTENTIALLY RELEVANT FINDING. BASED ON THE INFORMATION PROVIDED, THE POTENTIAL ROOT CAUSE OF THIS ISSUE IS DESIGN RELATED. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE BROKEN VIALS FOUND IN KIT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE BROKEN VIALS FOUND IN KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136762 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F18L0195

    Patients

    Seq Age Sex Outcome Treatment
    1