BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLYTE SYRINGES

    MDR report key: 964985 · Received December 13, 2007

    Report

    Report Number
    2432235-2007-00048
    Event Type
    Other
    Date Received
    December 13, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 12, 2007
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    FMF
    PMA / PMN Number
    K911638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A BIOHAZARDOUS ENVIRONMENT. THIS EVENT IS DUE TO OPERATOR ERROR AND IS COVERED IN THE PRODUCT LABELING. THE FOLLOWING STATEMENT IS IN THE "FILTER CAP INSTRUCTIONS FOR USE" SECTION OF THE PACKAGE INSERT: STOP PUSHING THE PLUNGER WHEN SAMPLE WETS THE FILTER. PRESSURE MAY RELEASE FILTER CAP DEVICE. FOR MEDICAL DEVICE REPORTING PURPOSES, THIS EVENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TWO OPERATOR INCIDENTS WHERE THEY WERE EXPOSED TO BLOOD WHEN THE FILTER CAP DISLODGED FROM THE RAPIDLYTE AUTOVENTING 3 ML SYRINGES THEY WERE USING. IN ONE INCIDENT, BLOOD SPRAYED IN THE OPERATOR'S EYES AND IN THE SECOND INCIDENT, BLOOD SPRAYED IN THE OPERATOR'S MOUTH. BOTH OPERATORS FOLLOWED THEIR FACILITY GUIDELINES FOR BODY FLUID EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLYTE SYRINGES SYRINGES FMF SMITHS MEDICAL ASD INC. 3 ML AUTO VENTING 1151671

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other