BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60 ML BD SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 2945763 · Received February 1, 2013

    Report

    Report Number
    1911916-2013-00001
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    December 24, 2012
    Report Date
    February 1, 2013
    Manufacturer
    BD
    Product Code
    FMF
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. DHR WAS REVIEWED AND NO QUALITY NOTIFICATIONS WERE NOTED FOR PACKAGED LOT # 2241483. THERE WERE TWO DIFFERENT MOLDING LOTS WENT TO THE PACKAGED LOT # 2241483. THERE WAS ONE NCMR RAISED FOR ONE OF THE MOLDING BATCH FOR VOID IN THE MOLDING CAVITIES. WITHOUT RETURN SAMPLE, UNABLE TO DETERMINE MOLDING LOT NUMBER FOR DEVICE INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 1

    SYRINGE TIP CRACKED INSIDE AN ALARIS MICROBORE TUBING SET AND DELAYED EPINEPHRINE ADMINISTRATION. ACCORDING TO THE REPORTER THERE IS NO WAY TO SAY THAT THE PT WOULD NOT HAVE REQUIRED INTUBATION; HOWEVER, THE LOW BLOOD PRESSURE ON THE PT RESULTED FROM THE FAILURE TO RECEIVE THE PROGRAMMED DOSE OF EPINEPHRINE INFUSION CONTRIBUTED TO THE PROVIDER'S DECISION TO INTUBATE THE PT. THE PT WAS WEANED OFF THE EPINEPHRINE AND HAD THE BREATHING TUBE REMOVED. HIS HEART FUNCTION IS IMPROVING AND HE IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43783 60 ML BD SYRINGE WITH BD LUER-LOK TIP SYRINGE, HYPODERMIC FMF BD 2241483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention