BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN SYRG MIS 0.5 / 31G

    MDR report key: 8822820 · Received July 23, 2019

    Report

    Report Number
    MW5088340
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BD
    Product Code
    FMF
    UDI-DI
    08290328468
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER STATES THAT WHEN SHE TRIES TO INJECT THE ZOMACTON THE "NEEDLE IS VERY LOOSE AND THEN BENDS" WHEN SHE INJECTS HER CHILD. THE CALLER SAID THE CHILD BLEEDS WHEN SHE INJECTS WITH THESE NEEDLES AND THINKS THEY ARE DEFECTIVE. THE CALLER SAID THAT THE PT STATES THAT THESE INJECTIONS HURT TOO BAD WITH THESE NEEDLES AND THEY HAVEN'T ADMINISTERED A DOSE SINCE (B)(6) 2019. PT WAS MISSED 4 DOSES SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612544 INSULIN SYRG MIS 0.5 / 31G SYRINGE, PISTON FMF BD 08290328468

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR