BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 2070571 · Received March 29, 2011

    Report

    Report Number
    1920898-2011-00007
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BD CONSUMER HEALTHCARE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RC RECEIVED 2 OPENED 1 ML X 29G X 1/2" SAFETYGLIDE INSULIN SYRINGES (LOT # 0050896). SAMPLES WERE AUTOCLAVED PER INTERNAL PROCEDURE AT 250 DEGREES FAHRENHEIT FOR 30 MINUTES. THE 2 SYRINGES WERE EVALUATED BOTH EXHIBITED A LOOSE NEEDLE/HUB ASSEMBLY WITH ADAPTOR AND SAFETY SHIELD ALREADY ACTIVATED. AS PART OF OUR INVESTIGATION, A REVIEW OF THE COMPLAINT DATABASE WAS CONDUCTED FOR THE INDICATED LOT NUMBER (LOT # 0050896) AND AS OF THIS DATE, REVEALED NO OTHER INCIDENTS OF THIS NATURE. IN ADDITION, A THREE YEAR REVIEW OF THE REORDER NUMBER WAS CONDUCTED AND AS OF THIS DATE REVEALED NO TRENDS FOR THIS CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS LOT. INSPECTIONS WERE PERFORMED TO VERIFY PROPER ACTIVATION OF THE SAFETY DEVICE. NO DEFECTS OR NOTIFICATIONS WERE NOTED DURING THE PRODUCTION OF THIS LOT.

    Description of Event or Problem · 1

    THREE CLINICIANS EXPERIENCED A NEEDLESTICK INJURY WITH THE SAFETYGLIDE INSULIN SYRINGE. IN ALL THREE INCIDENTS, THE CLINICIAN STUCK HIMSELF IN THE THUMB OF THEIR NON-DOMINANT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAFETYGLIDE 1ML 29G1/2" SAFETYGLIDE INSULIN SYRINGE FMF BD CONSUMER HEALTHCARE 0050896

    Patients

    Seq Age Sex Outcome Treatment
    1