BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE SMALL BORE EXTENSION SETS

    MDR report key: 3850806 · Received March 21, 2014

    Report

    Report Number
    9614279-2014-00009
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    February 26, 2014
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIVE USED CARESITE Y-EXTENSION SETS, AND ONE OPENED PACKAGE IDENTIFYING THE REPORTED LOT # 0061276549, WERE RECEIVED FOR EVALUATION. THE Y-EXTENSION SET (CATALOG #470106) CONTAINS TWO CARESITE VALVES PER SET. ON THE FIRST SAMPLE, ONE OF THE CARESITE VALVES WAS OBSERVED TO BE BROKEN OFF AT THE BONDED JOINT OF THE FEMALE ADAPTER. IT APPEARS THE VALVE WAS SUBJECTED TO AN EXCESSIVE FORCE WHICH LIKELY CAUSED THE VALVE TO BREAK OFF. ON THE SECOND, THIRD, AND FOURTH SAMPLES, A CRACK WAS OBSERVED ON THE FEMALE LUER THREADS OF THE MOLDED CARESITE VALVE BODY ON ONE OF THE TWO CARESITE VALVES CONTAINED ON EACH SET. ON THE FIFTH SAMPLE, NO CRACKS WERE OBSERVED ON EITHER CARESITE VALVE OF THE SET. HOWEVER, A SEPARATE CARESITE VALVE WAS ATTACHED TO THE SPINLOCK ADAPTER AT THE DISTAL END OF THE SET. THIS VALVE CONTAINED A CRACK ON THE FEMALE LUER THREAD OF THE MOLDED CARESITE VALVE BODY. THE DHR RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO NONCONFORMANCES OR ABNORMALITIES WERE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALTHOUGH THE DURATION OF USE FOR THE CARESITE VALVE COULD NOT BE CONFIRMED, IT IS INDICATED ON THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER, "THE CARESITE LUER ACCESS DEVICE IS COMPATIBLE WITH LIPID EMULSION AND CYTOTOXIC AGENTS CONTAINING CREMOPHOR (E.G. PACITAXEL) FOR 24 HOURS." BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENTS. 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 HAD FIVE SETS LEAK AT THE BODY OF THE VALVE, BUT UNSURE OF THE EXACT LOCATION. THE SETS LEAKED CHEMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169503 CARESITE SMALL BORE EXTENSION SETS SMALLBORE Y-EXTENSION SET W/ 2 CARESITES FPA B. BRAUN DOMINICAN REPUBLIC NA 0061276549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other