BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAPHY BALLOON SET

    MDR report key: 2852157 · Received November 12, 2012

    Report

    Report Number
    2242445-2012-00134
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    GBZ
    PMA / PMN Number
    K905229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE SURGERY DEPARTMENT. PRIOR TO USE, THEY FILLED THE SYRINGE TO THE PROPER LEVEL AND PRE-TESTED THE BALLOON. AT WHICH TIME, THE BALLOON BROKE. AS A RESULT, ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY FOR THE PATIENT. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLANGIOGRAPHY BALLOON SET CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK