BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7669-MIN MINOR KIT

    MDR report key: 6107137 · Received November 16, 2016

    Report

    Report Number
    9612030-2016-00660
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    November 2, 2017
    Manufacturer
    COVIDIEN
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. ONE SAMPLE WITHOUT AN ORIGINAL PACKAGE AND LOT NUMBER WAS RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED AND INDICATED FRAYING SPONGE. THE REPORTED CONDITION WAS CONFIRMED. THE REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATED THAT NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE ISSUE AS DESCRIBED BY THE CUSTOMER. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT DURING THE PRODUCTION PROCESS ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS. THE RETURNED SAMPLE DID NOT MEET THE QUALITY REQUIREMENT SPECIFICATIONS. THE POSSIBLE ROOT CAUSE INDICATED THAT THE ISSUE MAY BE RELATED TO THE SUPPLIED GRAY GAUZE ROLL THAT CONTAINED THE BROKEN THREAD OR INTRODUCED DURING THE JUMBO ROLL CUTTING PROCESS AND THE OPERATORS MAY NOT DETECT OR CLEAN IN TIME WHICH EVENTUALLY LED TO THE FINAL PRODUCT. AS A CORRECTIVE ACTION TO THE REPORTED CONDITION A NOTIFICATION WAS GIVEN TO ALL THE PERSONNEL¿S TO MAKE THEM AWARE OF THE CONDITION, THE INSPECTORS WERE INSTRUCTED TO IDENTIFY THE ISSUE IN A TIMELY MANNER, REINFORCED TRAINING HAS BEEN PROVIDED TO THE FOLDING OPERATORS TO ADHERE THE VISUAL INSPECTION PROCEDURES STRICTLY, LAP SPONGE WILL BE FULLY UNFOLDED AND STRETCHED BY TWO HANDS FOR ANY VISIBLE DEFECT DETECTION, THE OPERATORS HAVE BEEN INSTRUCTED TO CLEAN THE LOOSE THREAD ACCORDING TO THE SPECIFICATIONS, THE FACTORY HAS INFORMED THE GRAY LAP SPONGE / GAUZE ROLL SUPPLIER TO PREVENT THE BROKEN THREAD INSIDE THE RAW MATERIAL DURING THE WEAVING PROCESS, THE JUMBO ROLL CUTTING OPERATORS HAVE BEEN INSTRUCTED TO STRICTLY FOLLOW THE FACTORY SOP TO ROUTINELY MAINTAIN THE SHARPNESS OF THE CUTTING BLADE OR MAKE REPLACEMENT IMMEDIATELY IF NECESSARY IN ORDER TO REDUCE THE AMOUNT OF SHORT FIBERS GENERATED DURING THE CUTTING PROCESS, A DESIGNATED PERSONNEL IS ASSIGNED TO INSPECT EACH GAUZE SPONGE AFTER AUTOMATED MACHINE FOLDING PROCESS, THE ENGINEERING DEPARTMENT HAS MODIFIED THE CONVEYOR SURFACE OF GAUZE PACKING EQUIPMENT TO REMOVE ANY ROUGH OBJECT TO ENSURE THE SMOOTH SURFACE, TO ENSURE THE FACTORY¿S INSPECTION PROCEDURES ARE EFFECTIVE, WE HAVE INSTRUCTED OUR INSPECTORS TO PAY SPECIAL ATTENTION WHEN PERFORMING THE INSPECTIONS OF THE IN-PROCESS AND FINISHED PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A MINOR KIT. THE CUSTOMER REPORTS THAT THE RAYTEC WAS FRAYING. THIS WAS NOTED DURING COUNT AND IT WAS REMOVED FROM THE FIELD IMMEDIATELY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE RAYTEC WAS FRAYING. THIS WAS NOTED DURING COUNT AND IT WAS REMOVED FROM FIELD IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758139 7669-MIN MINOR KIT MINOR KIT KDD COVIDIEN 573830D 6137103464

    Patients

    Seq Age Sex Outcome Treatment
    1