BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTAN CHOLANGIOGRAPHY SET

    MDR report key: 2969860 · Received February 15, 2013

    Report

    Report Number
    2242445-2013-00026
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    GBZ
    PMA / PMN Number
    K905229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED. THE CLINICAL MANAGER STATES THEY ARE NOT SURE THIS BALLOON WAS IN THE PATIENT WHEN IT RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67422 PERCUTAN CHOLANGIOGRAPHY SET CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTL., INC. MF2027234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK