BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROBORE EXTENSION SET

    MDR report key: 2182299 · Received July 26, 2011

    Report

    Report Number
    MW5021504
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 19, 2011
    Manufacturer
    HOSPIRE
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO ED WITH ABDOMINAL PAIN AND PER PROTOCOL, IV ACCESS WAS PERFORMED. A 20 GAUGE ANGIOCATH WAS INSERTED IN THE PT'S ANTECUBITAL AREA AND A SALINE LOCK WAS PLACED. MD ORDERED A CT OF THE ABDOMEN WITH ORAL CONTRAST AND IV CONTRAST. CT TECHNOLOGIST BEGAN USING A POWER INJECTOR TO INSERT THE IV CONTRAST (OPTIRAY). THE INJECTOR WAS CONNECTED TO THE EXTENSION SET. THE TUBING OF THE EXTENSION SET RUPTURED DURING THE PROCESS OF ADMINISTRATION OF CONTRAST. STAFF IMMEDIATELY INTERVENED AND THERE WAS NO INJURY TO THE PT. INVESTIGATION (TELEPHONE CALL TO COMPANY REP) REVEALED THAT THIS SALINE LOCK IS NOT RECOMMENDED FOR USE WITH POWER INJECTORS BECAUSE IT CAN'T WITHSTAND 300 PSI. SECOND EXTENSION SET ALSO RUPTURED. STAFF AGAIN IMMEDIATELY INTERVENED AND THERE WAS NO INJURY TO THE PT. THE PT HAD RECEIVED SUFFICIENT CONTRAST TO BE ABLE TO COMPLETE THE STUDY. INDIVIDUAL PACKAGING READS, "BEFORE USING, CONFIRM COMPATIBILITY AND FLOW WITH CONNECTING DEVICE. SEE INSERT." THE INSERT (PRODUCT COMPATIBILITY NOTICE) IS ONE INSERT IN A BOX OF MANY AND THE INDIVIDUAL SETS ARE PLACED IN THE PYXIS MACHINES. THE ED NURSING STAFF NOR THE RADIOLOGY STAFF WAS AWARE THAT THESE EXTENSION SETS WERE NOT SAFE FOR USE WITH A POWER INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROBORE EXTENSION SET SALINE LOCK FPA HOSPIRE 94127NS
    2 MACROBORE EXTENSION SET SALINE LOCK FPA HOSPIRA 94127NS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention