BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE - W 20 GA 1 1/4 IN

    MDR report key: 37565 · Received July 12, 1996

    Report

    Report Number
    37565
    Event Type
    Injury
    Date Received
    July 12, 1996
    Date of Event
    February 16, 1996
    Report Date
    March 6, 1996
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REMOVED OWN HEP LOC AT 0430 2/16. PT REFUSED WARM COMPRESSES ALTHOUGH SITE WAS WARM, RED AND EDEMATOUS FROM KNUCKLE TO AFTER WRIST. A 20G 1 1/4 WAS INSERTED ON 2/13 AT 1630 IN L WRIST IN TC. PT REMOVED CATHETER ON 2/16 AT 0430. SITE WAS EXAMINED ON 2/15 1500 AND FOUND TO BE REDDENED BUT WITHOUT PAIN. ON 2/17 TREATMENT WITH IV ANTIBIOTIC AND WARM COMPRESSES. RECEIVED IV WITH KCL 20 MEQ @ 100 CC/HR. FLUSHED LOCK WITH 0.9% SALINE EVERY 8 HR. ON 2/17 TREATMENT WITH ANCEF 1 GM EVERY 8 HR FOR CELLULITIS. EXPIRATION DATE 10/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE - W 20 GA 1 1/4 IN 20 GA 1 1/4 IN FOZ BECTON DICKINSON & CO. NA H5MA370

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R