BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLINE CT

    MDR report key: 3842969 · Received May 27, 2014

    Report

    Report Number
    MW5036377
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDICAL COMPONENTS, INC
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT IN CT WITH RIGHT INTERNAL JUGULAR VENOUS DOUBLE LUMEN POWER LINE RATED AT 5ML PER SECOND. LINE CLEARED FOR USE AND WAS FLUSHED AND GOOD BLOOD RETURN. UPON INJECTION OF CONTRAST AT 4 ML/SEC, GRAPH SHOWED RINSE, PLATEAU AND THEN SUDDEN DROP IN PRESSURE. LINE WAS FOUND BUSTED WITH BLOOD FLOWING OUT. LINE IMMEDIATELY CLAMPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311805 PROLINE CT NONE LJS MEDICAL COMPONENTS, INC MR28037201 MFTM940

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention