BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD POSIFLOW POSITIVE DISPLACEMENT VALVE

    MDR report key: 2012323 · Received March 4, 2011

    Report

    Report Number
    9610847-2011-00007
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE SAMPLE IS NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS AND MATERIAL REVIEW REPORT DATABASE COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. 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

    APPROX 5 ML OF CYTARABINE CHEMOTHERAPY DRUGS LEAKED FROM THE BD POSIFLOW RESEAL. THERE WAS NO HARM TO THE CLINICIAN OR PT AS A RESULT OF THE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD POSIFLOW POSITIVE DISPLACEMENT VALVE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other