BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1040771 · Received May 9, 2008

    Report

    Report Number
    1219856-2008-00221
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 15, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE STOPCOCK AT THE END OF THE SHORT PIECE OF PIGTAIL TUBING (THAT CONNECTS CENTRAL LUMEN TO DISPOSABLE TRANSDUCER SETUP) WAS LEAKING AT THE STOPCOCK END AND CONTINUES TO HAPPEN. THIS HAPPENED IN THE OPERATING ROOM SO IT WAS DIFFICULT TO GET TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK