BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY IV START KIT WITH CHLORAPREP FREPP APPLICATOR

    MDR report key: 918946 · Received September 24, 2007

    Report

    Report Number
    MW5003893
    Event Type
    Injury
    Date Received
    September 24, 2007
    Date of Event
    September 15, 2007
    Report Date
    September 24, 2007
    Manufacturer
    TRINITY STERILE INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING PREPPED WITH CHLORAPREP FREPP APPLICATOR WHEN IT WAS NOTED THAT HER SKIN WAS BEING SCRATCHED AND SOME BLEEDING NOTED. PATIENT'S LEFT ARM WITH DEEP, ELONGATED SCRATCH MARKS SECONDARY TO THE CHLORAPREP USE. NURSE DISCONTINUED THE USE OF THE FREPP AND PROVIDED FIRST AID. IV STARTED WITH ANOTHER START KIT AND NO UNTOWARD REACTION NOTED. LOT # 30694 IV START KITS WERE PULLED FROM THE SUPPLY CARTS AND MATERIALS MGMT AND ARE IN DQM'S OFFICE. THE ACTUAL FREPP THAT CAUSE THE INJURY IS ALSO SECURED IN THE DQM'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINITY IV START KIT WITH CHLORAPREP FREPP APPLICATOR IV START KIT WITH CHLORAPREP FREPP APPLICATOR FOZ TRINITY STERILE INC. 30694

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR