BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEDAY UNIVERSAL IV SET

    MDR report key: 3823040 · Received January 17, 2014

    Report

    Report Number
    9614279-2013-00087
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 20, 2013
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K955585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE DHR RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO NONCONFORMANCES OR ABNORMALITIES WERE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT # 5: REPORTS OF FIVE SETS LEAK AT THE Y-SITE. CHEMO WAS INFUSING WHEN THE LEAKS WERE NOTED. THE REPORTER IS UNSURE IF THE Y-SITE WAS ACCESSED OR NOT WHEN THE LEAKAGES OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46188 SAFEDAY UNIVERSAL IV SET UNIVERSAL IV SET W/ONE BLUE ULTRASITE FPA B. BRAUN OF DOMINICAN REPUBLIC NA 0061315916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK