BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INTRACATH IV CATHETER

    MDR report key: 2062804 · Received April 8, 2011

    Report

    Report Number
    9610048-2011-00001
    Event Type
    Other
    Date Received
    April 8, 2011
    Report Date
    September 18, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO YEAR RETROSPECTIVE REVIEW OF SIMILAR PRODUCTS SOLD INTO THE US THAT ARE MANUFACTURED AND SOLD BY BD OUTSIDE OF THE US. REFERENCE: (B)(4). THE REPORT WAS RECEIVED FROM (B)(4). THE HOSP AND PT INFO ARE CONFIDENTIAL AND WILL NOT BE RELEASED. RESULTS: THE SAMPLE WAS NOT AVAILABLE FOR EVAL. A REVIEW OF THE LOT HISTORY RECORDS WERE REVIEWED AND NO IRREGULARITIES WERE NOTED DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7170868. CONCLUSIONS: SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVAL, WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THE PROBLEM ENCOUNTERED. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER BROKE WHILE INDWELLING, LEAVING APPROX 5 CM IN THE PT. THE PT WAS IMMEDIATELY DIRECTED TO THE SECTOR OF HEMODINAMICA, WHERE THE CATHETER WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INTRACATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7170868

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other