BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTAN CHOLANGIOGRAPHY SET

    MDR report key: 1311954 · Received November 25, 2008

    Report

    Report Number
    2242445-2008-00043
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 25, 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
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY WERE PERFORMING AN INTRAOPERATIVE CHOLANGIOGRAM (IOC) ON A PT. WHEN ATTEMPTING TO INJECT CONTRAST THROUGH THE CATHETER FROM LOT MF7033716, VISIPAQUE (NDC) MIXED 50/50 WITH INJECTABLE SALINE, THE MEDIA WOULD NOT PASS THROUGH THE CATHETER. A SECOND CATHETER FROM LOT MF7033716 WAS OPENED AND THE SAME SCENARIO. THE SURGEON REMOVED THE SYRINGE FROM THE CATHETER AND IT FLUSHED JUST FINE, BUT NOT THROUGH THE CATHETER. A THIRD CATHETER FROM LOT MF8051021 WAS OPENED, AND THEY HAD NO SUCCESS. AS A RESULT, THE SURGEON DID NOT COMPLETE THE IOC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTAN CHOLANGIOGRAPHY SET CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTL., INC. MF8051021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK VISIPAQUE (NDC) MIXED 50/50 WITH INJECTABLE SALINE