BEUDAMED
    FDA Adverse Event Summary report: N

    EZ IO INTRAOSSEOUS NEEDLE SET

    MDR report key: 2832001 · Received November 9, 2012

    Report

    Report Number
    MW5027600
    Date Received
    November 9, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 29, 2012
    Manufacturer
    VIDACARE CORP
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDICS RESPONDED TO CARDIAC ARREST IN (B)(6) NEONATE. EZ I/O 15MM 15 GAUGE NEEDLE WAS PLACED IN LEFT TIBIA CORRECTLY BUT WHEN INNER TROCAR REMOVED, MEDIC WAS UNABLE TO CONNECT EXTENSION TUBING, IV TUBING NOR A SYRINGE TO THE INFUSION CANNULA THAT WAS IN THE OSSEOUS SPACE. LOT NUMBER AV10G03 EXPIRATION DATE 7/2014. ACTUAL CANNULA WAS RETRIEVED FROM PT FROM THE OFFICE OF THE MEDICAL EXAMINER AFTER AUTOPSY. WHEN INSPECTED THERE IS A THREAD ISSUE THAT PREVENTS LUER LOCK TYPE CONNECTOR TO ADVANCE AND LOCK ONTO THE MALE THREADED END OF THE INFUSION CANNULA. REMAINDER OF THE LOT WAS TAKEN OUT OF SERVICE AND THE ACTUAL NEEDLE AND CANNULA WILL BE RETURNED TO VIDACARE FOR EVALUATION ALONG WITH OTHER NEEDLES FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ IO INTRAOSSEOUS NEEDLE SET EZ I/O 15MM 15 GUAGE NEEDLE SET FMI VIDACARE CORP 9018 AV10G03

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death| O