BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEDAY IV ADMINISTRATION SET

    MDR report key: 6067348 · Received October 31, 2016

    Report

    Report Number
    9614279-2016-00073
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Report Date
    October 7, 2016
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K955585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO SAMPLES RECEIVED FOR EVALUATION IN CONNECTION WITH THE REPORTED INCIDENT. MULTIPLE ATTEMPTS MADE TO CONTACT THE FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT WERE UNSUCCESSFUL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH SAMPLE ANALYSIS OR BATCH RECORD REVIEW 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE ROLLER CLAMP IS NOT CLAMPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718600 SAFEDAY IV ADMINISTRATION SET SAFEDAY IV ADMINISTRATION SET FPA B. BRAUN DOMINICAN REPUBLIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1