BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS SAFETY NEEDLE

    MDR report key: 20097936 · Received August 28, 2024

    Report

    Report Number
    MW5159003
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 23, 2024
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSING STAFF USED THE NEEDLES TO ADMINISTER IMMUNIZATIONS TO (B)(6) RESIDENTS IN OUR HEALTH OFFICER'S CLINIC AND IN OUR BACK-TO-SCHOOL IMMUNIZATION CLINIC. STAFF REPORTED THE NEEDLE SAFETY ARE FAULTY AND UNSAFE TO USE. THE FOLLOWING SAFETY ISSUES WERE REPORTED BY NURSING STAFF: FORCE NEEDS TO BE USED TO ENSURE THE SAFETY ENGAGES; NEEDLES ARE BENDING OUT OF THEIR SAFETY HUBS; INTERMITTENTLY THE NEEDLES ARE DULL WHICH IS DANGEROUS AND PAINFUL TO THE PATIENTS AS MORE FORCE NEEDS TO BE USED TO PUNCH THEM THROUGH THE SKIN; INTERMITTENTLY THE NEEDLES ARE COMING OUT THROUGH THE BACK OF THE SAFETY. REFERENCE REPORTS: MW5159000, MW5159001, MW5159002, MW5159004, MW5159005. ALL DPS SAFETY NEEDLES HAVE BEEN REMOVED FROM OUR CLINICS AND DISCARDED. THE FOLLOWING IS THE INFORMATION FOR THE FAULTY DISCARDED NEEDLES: DPS SAFETY NEEDLES, 25G X 1 INCH. LOT W2106073, EXP. 6/03/2026, REF. 100800000066 LOT W2106094, EXP. 6/18/2026, REF. 100800000066 LOT W2106074, EXP. 6/04/2026, REF. 100800000066 LOT W2105098, EXP. 5/08/2026, REF. 100800000066 LOT W2105099, EXP. 5/09/2026, REF. 100800000066 LOT W2106078, EXP. 6/06/2026, REF. 100800000066.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522616 DPS SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI DUOPROSS MEDITECH CORPORATION 100800000066 W2105098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other