BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORMALLY CLOSED CHECK VALVE/ANTISIPHON VALVE

    MDR report key: 3192444 · Received June 19, 2013

    Report

    Report Number
    2523676-2013-00171
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K942988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER OR REPORTED LOT NUMBER. NO ADVERSE TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS. REVIEW OF THE NONCONFORMING LOT REPORT DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCE OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. IF ADD'L PERTINENT INFO BECOMES AVAILABLE. A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS FOUR INCIDENTS OF VALVE LEAKAGE DURING CHEMOTHERAPY. NO SAMPLES AVAILABLE AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279468 NORMALLY CLOSED CHECK VALVE/ANTISIPHON VALVE BC1000 BACKCHECK VALVE ASSY FPA B. BRAUN MEDICAL, INC. BC1000 0061202239

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK