BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO CHOLANGIOGRAPHY SET

    MDR report key: 3786732 · Received February 6, 2014

    Report

    Report Number
    2242445-2014-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 17, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FGE
    PMA / PMN Number
    K905229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE SURGERY DEPARTMENT. THEY REPORTED THAT THE BALLOON WOULD NOT INFLATE. AS A RESULT, ANOTHER KIT WAS OPENED. SEE MDR 2242445-2014-00002 FOR THE NEXT KIT USED WITH THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78486 INTRO CHOLANGIOGRAPHY SET CHOLANGIOGRAPHY CATHETER PRODUCTS FGE ARROW INTL., INC. MF3022692

    Patients

    Seq Age Sex Outcome Treatment
    1