BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS BARE HYPODERMIC SYRINGE 1ML

    MDR report key: 11581134 · Received March 26, 2021

    Report

    Report Number
    MW5100312
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 24, 2021
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER REPORT FROM STAFF AT SITE, WHEN A STUDENT NURSE WAS ATTEMPTING TO INJECT A SECOND DOSE OF MODERNA COVID VACCINE, THE SYRINGE CAME APART AND THE DOSE WAS WASTED. GIVEN REPORTS OF PRIOR ISSUES WITH THE HAIOU SYRINGE, I WOULD LIKE TO REPORT THIS SYRINGE IN CASE THERE HAVE BEEN OTHER INCIDENTS: NEEDLE AND SYRINGE INFORMATION: MCKESSON 25G X1" NEEDLE, DPS BARE HYPODERMIC SYRINGE 1ML. THIS EVENT WAS ALSO REPORTED ON VAERS AND TO THE COVID CALL CENTER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475196 DPS BARE HYPODERMIC SYRINGE 1ML SYRINGE, PISTON FMF DUOPROSS MEDITECH CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR