BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGES WITH ULTRA FINE NEEDLE 1CC 30G, 1/2 INCH

    MDR report key: 2440515 · Received February 1, 2012

    Report

    Report Number
    MW5024123
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 1, 2012
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN USING INSULIN VIA SYRINGE FOR YEARS WITHOUT PROBLEM. SPOUSE DRAWS IT UP AND HAS RARELY HAD PROBLEMS WITH NEEDLES OR SYRINGES. THE PLASTIC HOUSING NEAR THE NEEDLE ON BD INSULIN SYRINGE 1ML 30 G WITH (B)(4) HAS BEEN CRACKED ON 5-6 PER WEEK (USES 21) FROM CONTROL NUMBER (B)(4). IT PREVENTS THEM FROM DRAWING UP THE INSULIN WITHOUT AN EXCESS AMOUNT OF BUBBLES. WHEN THE PT GOES TO INJECT, HE CANNOT PUSH THE PLUNGER TO ADMINISTER ALL THAT IS DRAWN UP. THEY HAVE TO SEE HOW MUCH IS LEFT IN THE SYRINGE AND REDRAW THAT AMOUNT FOR ADMINISTRATION OF HIS FULL DOSE. THIS HAPPENS WITH BOTH TYPES OF INSULIN HE USES (GLARGINE AND REGULAR). DATES OF USE: (B)(6): (B)(6) 2011 - (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSULIN SYRINGES WITH ULTRA FINE NEEDLE 1CC 30G, 1/2 INCH BD INSULIN SYRINGE FMF BD 1178289

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability