BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 3854082 · Received May 16, 2014

    Report

    Report Number
    2243072-2014-00103
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A PREPAID MAILING LABEL AND SHIPPING TUBE WERE SENT TO THE CUSTOMER FOR RETURN OF THE SAMPLE. TO DATE, NO SAMPLES HAVE BEEN RECEIVED. IF A SAMPLE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE NURSE WAS ATTEMPTING TO INSERT A 20 GA PERIPHERAL IV INTO THE PT'S RIGHT ANTECUBITAL VEIN. THE ATTEMPT WAS UNSUCCESSFUL. AS THE NURSE WITHDREW THE CATHETER, SHE NOTICED THE TIP WAS NO LONGER INTACT. AN X-RAY WAS PERFORMED WHICH SHOWED THE CATHETER TIP WAS IN THE SUBCUTANEOUS SKIN OF THE ARM APPROX 1 MM UNDER THE SKIN. A MINOR PROCEDURE AT THE BEDSIDE WAS PERFORMED TO REMOVED THE CATHETER TIP. THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293015 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3312751

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention