BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD BC SHILDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY

    MDR report key: 2935153 · Received January 25, 2013

    Report

    Report Number
    1710034-2013-00002
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PREPAID MAILING LABEL AND SHIPPING TUBE HAVE BEEN SENT TO THE CUSTOMER FOR RETURN OF THE SAMPLE. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED IN THE PT AND NO BLOOD RETURN WAS SEEN. THE NURSE PULLED BACK THE CATHETER AND NOTICED THAT THE TIP OF THE CATHETER WAS MISSING. THE PT WAS TAKEN FOR AN X-RAY, WHICH SHOWED A FRAGMENT OF THE CATHETER WAS IN THE PT'S ARM. THE CATHETER FRAGMENT WAS REMOVED. THE PT HAD NO ADDITIONAL PROBLEMS AND THE PT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36314 BD INSYTE AUTOGUARD BC SHILDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other