BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36 QUAD-FURCATED SCIG SET 27GX9MM NEEDLES

    MDR report key: 1174103 · Received September 23, 2008

    Report

    Report Number
    MW5008400
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    EMED CORP
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATED THE NEEDLES ON THE SUB-Q SET WERE DULL AND THEREFORE, UNABLE TO COMPLETE THE IMMUNOGLOBULIN INFUSION. (LOT #0804115) TREATMENT WAS STOPPED AND DRUG WASTED. PT DEVELOPED SEVERE BLACK AND BLUE MARKS AT SITES. IN 2008, THE INFUSION WAS RE-TRIED WITH A DIFFERENT LOT NUMBER OF THE SAME SET AND THAT SUB-Q SET WORKED FINE. (LOT # 0806020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36 QUAD-FURCATED SCIG SET 27GX9MM NEEDLES SUBCUTANEOUS SET FPA EMED CORP SUB-410 0804115
    2 36 QUAD-FURCATED SCIG SET 27GX9MM NEEDLES SUBCUTANEOUS SET FPA EMED CORP SUB-410 0806020

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR VIVAGLOBIN 9.6 G SUB-Q Q WEEKLY