BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 6114484 · Received November 18, 2016

    Report

    Report Number
    9614279-2016-00114
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Report Date
    September 9, 2014
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K931377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT THREE OF B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE COP-QP-8000051.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 3. SETS ARE LEAKING AND BLOOD BACKING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763045 IV ADMINISTRATION SET SET, ADMINISTRATION, INTRA FPA B. BRAUN DOMINICAN REPUBLIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1