BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1CC SAF SYR ETB 25X 5/8

    MDR report key: 2453865 · Received January 25, 2012

    Report

    Report Number
    1915484-2012-00009
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Report Date
    January 11, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY TB SYRINGE. THE CUSTOMER REPORTS A NUMBER OF SYRINGES BOTH INSULIN AND TB, ARE NOT LOCKING CORRECTLY. THE CUSTOMER STATES THERE IS A FLAW WHICH ALLOWS THE USER TO CONTINUE TO TWIST THE LOCKING MECHANISM AFTER IT HAS BEEN LOCKED, ALLOWING IT TO BECOME UNLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1CC SAF SYR ETB 25X 5/8 TB SYRINGE FMF COVIDIEN 8881511235 126111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK