BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC SAF.SYR 23X1

    MDR report key: 1468261 · Received July 24, 2009

    Report

    Report Number
    1650158-2009-00008
    Event Type
    Malfunction
    Date Received
    July 24, 2009
    Report Date
    July 21, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 07/21/2009 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY SYRINGE. CUSTOMER STATES THAT THE SEAL AROUND THE NEEDLE IS DEGRADED. WHEN NURSE INJECTED INTO THE PATIENT THE NEEDLE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3CC SAF.SYR 23X1 SAFETY SYRINGE MEG COVIDIEN 8881533338 63330128

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN