BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTI-CARE INSULIN SYRINGE

    MDR report key: 341738 · Received July 5, 2001

    Report

    Report Number
    MW4003030
    Event Type
    Malfunction
    Date Received
    July 5, 2001
    Date of Event
    June 29, 2001
    Report Date
    July 5, 2001
    Manufacturer
    ULTI MED, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT IS INSULIN DEPENDENT. PURCHASED 2 BOXES OF 100 EACH (BAGS PER BOX) OF EMPTY SYRINGES W/NEEDLES IN STERILE PACKAGES. 2 BAGS WERE FOUND IN ONE BOX WITH THE CAPS OFF. PT WAS POKED BY A 3RD NEEDLE WHILE OPENING A BAG. THE RPTR IS VERY CONCERNED ABOUT THE STERILITY OF THIS PACKAGE. THE RPTR CALLED THE PRESIDENT OF ULTI-MED, MFG OF THE PRODUCT WHO SAID THAT THEY HAVE RECEIVED SEVERAL COMPLAINTS ABOUT THIS SAME PRODUCT AND THAT THEY ARE WORKING ON CHANGING THE PRODUCT SO THIS WOULDN'T OCCUR. NO ADVERSE HEALTH EFFECTS SHOWING IN THE PT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30547 ULTI-CARE INSULIN SYRINGE INSULIN SYRINGE 30 GAUGE - 1CC FMF ULTI MED, INC. NA 00412

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR