BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TB SAFETY SYRINGE 1CC 28G X1/2IN

    MDR report key: 3070988 · Received April 1, 2013

    Report

    Report Number
    1915484-2013-00008
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/29/2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A TB SAFETY SYRINGE. THE CUSTOMER STATES THAT AFTER THE NURSE FINISHED THE INJECTION ON A PATIENT, THE SAFETY SHEATH CAME OFF THE NEEDLE. THE SAFETY SHIELD COMPLETELY DETACHED FROM THE DEVICE WHEN AN ATTEMPT WAS MADE TO ACTIVATE THE SHIELD. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133136 TB SAFETY SYRINGE 1CC 28G X1/2IN TB SYRINGE FMF COVIDIEN 8881511201 229833

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK