BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINOR PACK

    MDR report key: 6222926 · Received January 4, 2017

    Report

    Report Number
    9612030-2017-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Report Date
    November 16, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 01/04/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OUTSIDE OF ITS ORIGINAL PACKAGE AND WITH NO LOT NUMBER WAS RECEIVED FOR EVALUATION. AS PART OF THE ANALYSIS THE SAMPLE WAS VISUALLY INSPECTED ACCORDING TO PRODUCT SPECIFICATION; THE PHYSICAL SAMPLES CONFIRMS FRAYING SPONGES. THE REPORTED CONDITION BY THE CUSTOMER WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER COULD NOT BE PROVIDED BY THE CUSTOMER. A ROOT CAUSE, OR PROBABLE CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED BECAUSE THE COMPONENT CONSISTING OF AN X-RAY DETECTOR SPONGE, 4 INCH X 4 INCH, 16 PLY IS PRODUCED BY EXTERNAL SUPPLIER AND THE ASSEMBLY PROCESS CONSISTS IN A PICK AND PLACE OPERATION. THERE IS NO ADDITIONAL INSPECTION ON THE LINE TO DETECT THE CONDITION REPORTED. THE ROOT CAUSE ANALYSIS FROM OUR SUPPLIER IS DOCUMENTED THRU A SUPPLIERS CORRECTIVE/PREVENTATIVE ACTION (SCAR) DETERMINED THAT THE POSSIBLE ROOT CAUSE MAY BE RELATED TO THE SUPPLIED GRAY GAUZE ROLL THAT CONTAINED THE BROKEN THREAD OR INTRODUCED DURING THE JUMBO ROLL CUTTING PROCESS. OPERATORS MAY NOT DETECT OR CLEAN THEM IN TIME AND EVENTUALLY LED TO FINAL PRODUCT. A PRODUCTION NOTIFICATION WAS ISSUED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. THE INSPECTORS WERE INSTRUCTED TO PICK OUT THE DEFECT IN A TIMELY MANNER. THE REINFORCED TRAINING HAS BEEN PROVIDED TO FOLDING OPERATORS TO FOLLOW THE VISUAL INSPECTION PROCEDURE STRICTLY. LAP SPONGE WILL BE FULLY UNFOLDED AND STRETCHED BY TWO HANDS FOR ANY VISIBLE DEFECT DETECTION. 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. 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 SURGICAL SPONGE. THE CUSTOMER REPORTED THAT THE RAYTEC SPONGES, INCLUDED INSIDE THIS SUBASSEMBLY, ARE FLAKING PARTICLES. THE CUSTOMER STATED THAT THIS ISSUE WAS IDENTIFIED PRIOR TO USE WITH THE AFFECTED PRODUCT BEING REMOVED FROM THE FIELD AND NEW PRODUCT PULLED FOR USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6423 MINOR PACK SURGICAL SPONGE GDY COVIDIEN SA2204 6176104264

    Patients

    Seq Age Sex Outcome Treatment
    1