BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL

    MDR report key: 2125394 · Received June 2, 2011

    Report

    Report Number
    1030451-2011-00002
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE COMPLAINT UNIT FOR MEDICAL ACTION INDUSTRIES INC (B)(4) FACILITY RECEIVED A MEDWATCH FORWARDED BY (B)(6). MEDICAL ACTION HAD NOT PREVIOUSLY RECEIVED NOTIFICATION OF THIS COMPLAINT AND ASSIGNED COMPLAINT #(B)(4). (B)(6) WAS CONTACTED AND E-MAILED (B)(4) LABELS TO RETURN COMPLAINED SAMPLES. INVESTIGATION: MEDICAL ACTION REVIEWED THE DEVICE HISTORY RECORD OF THE TRAY THAT CONTAINED THE COMPLAINED CONNECTOR PART #(B)(4), LOT #0911035 AND NOTED NO NON-CONFORMANCES. INSPECTIONS WERE CONDUCTED OF TRAYS CONTAINING THE COMPLAINED RAW MATERIAL TO INCLUDE TRAYS BUILT WITH THE COMPLAINED RAW MATERIAL LOT # AND NO FURTHER NON-CONFORMANCES WERE FOUND. IN ADDITION THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS DEFECT. ACTION: MEDICAL ACTION FORWARDED THE COMPLAINED SAMPLES TO THE SUPPLIER, (B)(4). INJECTION TECHNOLOGY INC ISSUED (B)(4) IN RESPONSE TO THE COMPLAINT AND RESPONDED TO OUR SCAR WITH THE FOLLOWING: "THE SLIDE THAT MOVES THE CORE PIN THAT FORMS THE HOLE THROUGH THE CENTER OF THE PART WAS NOT TRAVELING THE FULL LENGTH NECESSARY TO FORM THE COMPLETED HOLE IN THE CENTER OF THE PART. THE LIMIT SWITCH WHICH ACTUATES THE MOVEMENT OF THIS SLIDE HAD A CABLE BEING PINCHED BETWEEN THE SIDE OF THE MOLD AND THE SLIDE WHICH PREVENTED IT FROM MOVING THROUGH ITS FULL STROKE. THIS CABLE HAS BEEN ATTACHED AWAY FROM THIS AREA TO PREVENT THIS FROM OCCURRING AGAIN. THE CABLES FOR THE LIMIT SWITCHES HAVE BEEN ATTACHED AWAY FROM PINCH POINTS TO PREVENT THEM FROM BINDING UP DURING MOLD CYCLES. ACTIONS COMPLETED (B)(4) 2011." MEDICAL ACTION HAS INCREASED INSPECTIONS TO MONITOR FUTURE SHIPMENTS AND WILL CONTINUE TO MONITOR FOR THIS DEFECT.

    Description of Event or Problem · 1

    CONNECTORS DO NOT ALLOW AIRFLOW TO PASS THROUGH. ONE END IS OPEN, THE OTHER END IS SEALED/CLOSED FULLY. PATIENT INFORMATION IS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL 5 IN 1 CONNECTOR BZA MEDICAL ACTION INDUSTRIES, INC. 56427 107078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention