BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE

    MDR report key: 2888560 · Received November 19, 2012

    Report

    Report Number
    2523676-2012-00234
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN A F/U CALL TO THE FACILITY, THE REPORTER STATED THAT THE PT WAS DOING FINE AND THAT THERE WAS NO NEED FOR ADD'L TREATMENT AS A RESULT OF THE LEAKAGE. THE REPORTER ALSO CONFIRMED THAT TPN WAS BEING ADMINISTERED AT THE TIME AND THAT THE USE OF THE VALVE IS ABOUT A 20 - 24 HOUR TIME PERIOD. ONE (1) USED CARESITE VALVE WITHOUT PACKAGING WAS RECEIVED FOR EVAL. THE SAMPLE WAS SUBJECTED TO A LEAKAGE TEST WITH FAILING RESULTS. THE SAMPLE WAS THEN EXAMINED UNDER MAGNIFICATION, AND A CRACK WAS NOTED IN THE CARESITE BODY BUT NOT ALONG THE KNIT LINE. A REVIEW OF THE NONCONFORMING LOT REPORT (NLR) DATABASE WAS PERFORMED FOR THE FINISHED GOOD AND INVOLVED MOLDED COMPONENT LOTS AND NO ABNORMALITIES OR NONCONFORMANCE'S WERE NOTED DURING IN-PROCESS OR AT FINAL PRODUCT INSPECTION. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED INCIDENT IS ON-GOING AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: "MOTHER STATES SHE FOUND HER CHILD IN A POOL OF BLOOD WHEN SHE GOT UP FROM HER NAP. SHE STATES THERE WAS A CRACK IN THE SIDE OF THE CARESITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESITE CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA 0061250151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other