BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE®

    MDR report key: 6134554 · Received November 30, 2016

    Report

    Report Number
    2523676-2016-00770
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    July 1, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04022495769862
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: WHEN DISCONNECTED FROM IV LINE, BLOOD WAS LEAKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786158 SAFSITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061432510 04022495769862

    Patients

    Seq Age Sex Outcome Treatment
    1