BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA # 18GA 1.00 IN 1.3X25MM

    MDR report key: 287227 · Received July 24, 2000

    Report

    Report Number
    MW1019366
    Event Type
    Other
    Date Received
    July 24, 2000
    Date of Event
    February 25, 2000
    Report Date
    February 26, 2000
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STARTING AN ADMISSION IV FOR INDUCTION. NEW IV CATHETER CALLED SAF-T-INTIMA. GOOD STICK, GOOD BLOOD FLASH BACK IN TUBING, ANCHORED BUTTERFLY WINGS, ATTEMPTED TO WITHDRAW STYLET AND FELT RESISTANCE, CONTINUED STEADY PULL PER MFR'S INSTRUCTION. TUBING SEPARATED FROM BACK OF BUTTERFLY. WITHDREW STYLET AND POSTERIOR PORTION OF TUBING AND LEFT BUTTERFLY WITH CATHETER IN PT'S VEIN WITH BLOOD FLOWING OUT. DIRECT PRESSURE WAS APPLIED TO SITE AFTER WITHDRAWAL OF BUTTERFLY/CATHETER UNTIL BLEEDING STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA # 18GA 1.00 IN 1.3X25MM IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. REF383346 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other RESTARTED IV WITH QUICK CATH IV CATHETER.