BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPIRA

    MDR report key: 1220649 · Received November 3, 2008

    Report

    Report Number
    MW5008842
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 3, 2008
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRIMARY IV PLUMSET TUBING LIFE SHIELD WHERE IT CONNECTS AT THE CLAVE, BROKE APART DURING PRE-MEDICATING A PATIENT DURING CHEMOTHERAPY. THE TUBING WAS CONNECTED TO AN INFUSAPORT. THERE WAS BLOOD BACKING UP INTO THE TUBING. THE BROKEN END WAS CLAMPED WITH PLASTIC CLAMP. NEW TUBING WAS PRIMED AND ATTACHED AFTER PORT WAS FLUSHED WITH 20 ML NS. ON FURTHER INSPECTION OF TUBING AND COMPARISON TO NEW UNUSED TUBING FOUND THAT THE DISTAL END OF THE TUBING IS MUCH MORE PLIABLE THAN THE REST OF THE LINE AND THIS IS NOT HOW THE TUBING USED TO BE. A NEW SET WAS OPENED BUT NOT USED ON THE PATIENT. THE TUBING WAS MODERATELY TUGGED ON AND BROKE IN THE SAME MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA IV TUBING FPA HOSPIRA * 67053

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability