BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA SHIELDED IV CATHETER

    MDR report key: 1003060 · Received February 22, 2008

    Report

    Report Number
    9610847-2008-00012
    Event Type
    Other
    Date Received
    February 22, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE BROKE BELOW THE WING BY A CHILD'S NAIL. THE HOSP QUESTIONED ABOUT THE DEVICE BEING TOO FRAGILE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other