BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAT-T-INTIMA IV CATHETER

    MDR report key: 2948274 · Received December 17, 2004

    Report

    Report Number
    9610847-2004-00016
    Event Type
    Other
    Date Received
    December 17, 2004
    Date of Event
    November 11, 2004
    Report Date
    December 6, 2004
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO FROM USER FACILITY REPORT: BRAND NAME: BECTON DICKINSON. COMMON DEVICE NAME: SAF-T-INTIMA 22GA 0.75 IN. (B)(6).

    Description of Event or Problem · 1

    THE NURSE INSERTED THE IV INTO THE PT AND DID NOT RECEIVE A FLASHBACK. SHE PULLED BACK ON THE STYLET AND BLOOD KEPT COMING OUT OF THE SITE. SHE PLACED GAUZE OVER THE INSERTION SITE AND PULLED THE CATHETER OUT OF THE PT, NOTICING THAT THE CATHETER WAS SHORTER THAN IT SHOULD BE. THE PT WAS TAKEN TO THE OPERATING ROOM TO SURGICALLY REMOVE THE PIECE OF CATHETER. NO ADVERSE AFFECTS TO THE PT WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAT-T-INTIMA IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS 383322 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other