BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHOGAM ULTRA-FILTERED PLUS

    MDR report key: 3250020 · Received July 26, 2013

    Report

    Report Number
    2250051-2013-00192
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYRINGE WAS DISCARDED AFTER USE, THEREFORE NO INVESTIGATION WAS PERFORMED. THERE ARE NO SIMILAR COMPLAINTS REGARDING THIS LOT OF PRODUCT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NURSE STUCK HERSELF WITH THE NEEDLE AFTER ADMINISTERING THE RHOGAM SYRINGE. THE RHOGAM WAS DISPENSED FROM THE BLOOD BANK TO BE ADMINISTERED BY THE NURSE. THE PATIENT RECEIVED THE FULL DOSE OF THE RHOGAM. THE NURSE INADVERTENTLY STUCK HERSELF WITH THE NEEDLE AFTER THE INJECTION WAS GIVEN. THE SYRINGE WAS DISCARDED AFTER THE INCIDENT. CUSTOMER STATED THE PATIENT AND THE NURSE WERE NEGATIVE FOR HIV AND HEPATITIS. THE NURSE WAS TREATED AND TESTED AS AN EXPOSURE INCIDENT. THE NURSE THAT ADMINISTERED THE NEEDLE HAD NO ILL EFFECTS FROM THE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350340 RHOGAM ULTRA-FILTERED PLUS RHO (D) IMMUNE GLOBULIN FMI ORTHO CLINICAL DIAGNOSTICS RVP199A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other