BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE (LAD)

    MDR report key: 4008335 · Received July 11, 2014

    Report

    Report Number
    2523676-2014-00270
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 DEVICES INVOLVED IN THE REPORTED INCIDENT WERE NOT RETURNED FOR EVAL; HOWEVER, THE FACILITY RETURNED ONE UNUSED CARESITE VALVE, IN ITS ORIGINAL PACKAGING INDICATING THE REPORTED LOT NUMBER 0061342332. AN UNUSED 3 ML BD SYRINGE WAS ALSO RETURNED. THE RETURNED CARESITE VALVE WAS SUBJECTED TO A WATER PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THE RETURNED 3 ML BD SYRINGE WAS THEN CONNECTED AND DISCONNECTED FROM THE CARESITE VALVE TEN CONSECUTIVE TIMES. THE CARESITE VALVE WAS THEN RE-TESTED FOR LEAKAGE ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. NO LEAKAGES WERE OBSERVED. REVIEW OF THE DISCREPANCY MGMT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMITIES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. WITHOUT THE ACTUAL USED SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED AT THIS TIME AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. 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 # 3: REPORTS BD SYRINGES ARE FILLED WITH A RADIO-ISOTOPE AND CONNECTED TO A CARESITE VALVE. THE RADIO-ISOTOPE LEAKED FROM THE CARESITE VALVE AS DROPLETS OF THE RADIO-ISOTOPE WERE FOUND ON THE PATIENT'S SKIN AND GOWN, AND ON THE NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408152 CARESITE (LAD) CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA 0061342332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK