BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM

    MDR report key: 2211435 · Received August 9, 2011

    Report

    Report Number
    9610847-2011-00048
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS REC'D ON 08.08.2011 AND SENT FOR DECONTAMINATION. ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE NURSE FOUND THE EXTENSION TUBING HAD SEPARATED FROM THE WINGED INSERTER DURING STYLET REMOVAL, WHICH RESULTED IN BLOOD LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other