BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE

    MDR report key: 2888561 · Received November 19, 2012

    Report

    Report Number
    2523676-2012-00235
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 17, 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. ONE (1) USED CARESITE VALVE ATTACHED TO A SMALLBORE Y-EXTENSION SET WAS RECEIVED FOR EVAL WITH PACKAGING. 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 ONGOING 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 HOOKED UP HER SON'S TPN THE SAME WAY EXCEPT THE ONLY DIFFERENCE WAS THE NEW CARESITE ACCESS SITE. SHE WAS NOT ABLE TO DISCERN WHERE THE LEAK OCCURRED DUE TO HER PANIC. SHE DID RETAIN THE SETUP." THE CARESITE VALVE IS ATTACHED TO A BROVIAC CATHETER. A B BRAUN 6 INCH Y EXTENSION SET IS ATTACHED TO THE CARESITE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESITE CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA 0061254538

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other