BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE (LAD)

    MDR report key: 3932252 · Received April 4, 2014

    Report

    Report Number
    2523676-2014-00089
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 8, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC. INTERNAL REPORT #: (B)(4). ONE USED CARESITE VALVE, WITHOUT PACKAGING, WAS RECEIVED FOR EVALUATION. THREE CRACKS AND SEVERAL CRAZING LINES/STRESS MARKS WERE OBSERVED ON THE FEMALE LUER LOCK THREAD OF THE MOLDED CARESITE VALVE BODY (CAVITY # 26B). THE CRACKS STARTED FROM THE TOP OF THE VALVE AND EXTENDED DOWN TO THE BOTTOM OF THE LUER THREADS. REVIEW OF THE DISCREPANCY MGMT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ADD'L INFO RECEIVED FROM THE REPORTING FACILITY INDICATED THAT THE VALVE HAD BEEN IN USE FOR 3 DAYS WHEN IT BEGAN LEAKING. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER, "THE LUER ACCESS DEVICE IS COMPATIBLE WITH LIPID EMULSION (CONTAINED IN TPN SOLUTIONS) AND CYTOTOXIC AGENTS CONTAINING CREMOPHOR (E.G., PACLITAXEL) FOR 24 HRS." BASED ON THE ADD'L INFO RECEIVED, IT WOULD APPEAR THAT USING THE DEVICE BEYOND THE RECOMMENDED 24 HRS LIKELY CONTRIBUTED TO THE REPORTED LEAKAGE. 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 SEVERE LEAKAGE WAS OBSERVED AT THE CONNECTING SITE OF THE CARESITE VALVE WHEN USING A CAAD PUMP FOR A PT RECEIVING HOME TREATMENT. ADD'L INFO RECEIVED FROM THE REPORTING FACILITY INDICATED THAT CHEMO WAS SET TO INFUSE THROUGH A CAAD AMBULATORY PUMP AT 1.2ML/HR FOR 128 HRS. THE LEAKAGE BEGAN ON DAY 3. THE CHEMO MEDICATION USED WAS 5-FLUOROURACIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205474 CARESITE (LAD) CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA 0061336014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CAAD AMBULATORY PUMP