BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 12 FR X 16 CM

    MDR report key: 1052549 · Received May 22, 2008

    Report

    Report Number
    1036844-2008-00080
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT INTENDED FOR HIGH PRESSURE INJECTION. 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 CATHETER WAS INSERTED INTO A FEMALE PT'S INTERNAL JUGULAR. AT WHICH TIME, THEY PRESSURE INJECTED THROUGH THE LINE CAUSING A HOLE IN THE CATHETER. THE CLINICIAN DID NOT KNOW WHAT PSI WAS USED. MORE INFO HAS BEEN REQUESTED. AT THIS POINT, NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 12 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS. DQO ARROW INTERNATIONAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK