BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO CHOLANGIOGRAPHY SET

    MDR report key: 1349074 · Received December 22, 2008

    Report

    Report Number
    2242445-2008-00048
    Event Type
    Malfunction
    Date Received
    December 22, 2008
    Date of Event
    December 9, 2008
    Report Date
    December 22, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    GBZ
    PMA / PMN Number
    K905229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THEY HAD AN INCIDENT WHERE A PIECE OF BLUE PLASTIC WAS "SHAVED" OFF THE CATHETER AND WENT INTO THE PT. THEY REPORTED THIS HAPPENED WITH TWO CATHETERS IN THE SAME PT. MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO CHOLANGIOGRAPHY SET CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTL., INC. MF8071997

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK