BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-BAG PLUS DOCKING ASSITTOOL

    MDR report key: 2941229 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02740
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE USED IN THIS SITUATION IS 510(K) EXEMPT - CLASS II (SPECIAL CONTROLS); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. THE DEVICE UNDERWENT VISUAL INSPECTION AND WAS TESTED BY PULLING THE HANDLE TO ENSURE THE SLIDE FUNCTIONED PROPERLY. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE WAS NOT INDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) A MINI-BAG PLUS DOCKING ASSIST TOOL IN WHICH THE LEFT SIDE OF THE DOCKING ASSIST TOOL (PRODUCT CODE 2C4950) IS NOT WORKING CORRECTLY. THE CUSTOMER STATED THAT DURING DOCKING, CLICKING NOISE CAN BE HEARD. MEDICAL INFORMATION SPECIALIST (MIS) THEN HAD THE CUSTOMER FLIP THE DOCKING TOOL TO INSPECT THE GEARING. THE CUSTOMER DOES SEE A VISIBLE DIFFERENCE IN GEAR MATERIAL BETWEEN THE SIDE THAT DOES WORK. WHEN UNDER PRESSURE THE GEAR IS SKIPPING TEETH ON THE TRACK DURING THE DOCKING PROCESS. THE CUSTOMER HAS HAD THE DOCKING TOOL FOR APPROXIMATELY 2 YEARS. THE CUSTOMER CAN NOW SEE WHY TOOL IS NOT WORKING AND WILL CALL BAXTER REPRESENTATIVE FOR REPLACEMENT OPTIONS. CUSTOMER DOES NOT REQUIRE FOLLOW-UP AND WILL BE CONTACTING THEIR SALES REPRESENTATIVE FOR A REPLACEMENT DOCKING TOOL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46433 MINI-BAG PLUS DOCKING ASSITTOOL EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1