BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE-STRUNG COTTON BALLS

    MDR report key: 4722978 · Received March 6, 2015

    Report

    Report Number
    3010452421-2015-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    February 5, 2015
    Report Date
    October 26, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EFN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDING: THE QFI WAS REVIEWED, IT WAS IDENTIFIED THAT RAW MATERIAL (B)(4),LOT NUMBER 61ND03 WAS UTILIZED WITHIN THE FINISHED GOOD AND LOT NUMBER REPORTED. THE RAW MATERIAL IS SUPPLIED TO DEROYAL BY (B)(4). THE 2013, 2014 AND 2015 SCAR LOG WAS REVIEWED AND PREVIOUS REPORTS WERE IDENTIFIED FOR THE RAW MATERIAL AND LOT NUMBER HAS BEEN RECEIVED. (B)(4) HAS BEEN ISSUED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED AS MORE INFO BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: GD MEDICAL SUPPLIES THE RAW MATERIAL (PART NUMBER 4-1223) TO (B)(4). IN ITS SUPPLIER CORRECTIVE ACTION REQUEST (SCAR), GD MEDICAL CONCLUDED THE ROOT CAUSE TO BE A MANUFACTURING ERROR AT THE RAW MATERIAL SUPPLIER LEVEL. THE COTTON IS PRODUCED ON A MACHINE, AND IT CAME OUT OF THE MACHINE TOO LOOSE. THE GRAM WEIGHT OF THE PRODUCT IS FIXED. THEREFORE, WHEN THE RAW MATERIAL SUPPLIER WRAPPED THE COTTON BALL, THE FINISHED GOOD WAS LARGER THAN NORMAL BUT REMAINED THE SAME WEIGHT. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTIVE ACTION TAKEN: GD MEDICAL IDENTIFIED IN ITS SCAR THAT THE RAW MATERIAL SUPPLIER HAS BEEN NOTIFIED TO ADHERE TO THE TECHNICAL STANDARDS. IF INSPECTORS FIND A PRODUCT OUT OF THE SPECIFIED RANGE, THEY WILL RETURN THE AFFECTED PRODUCT TO THE RAW MATERIAL SUPPLIER. BELOW IS THE MORE RIGOROUS INSPECTION PROCESS AND PRODUCT SPECIFICATIONS AS PROVIDED BY GD MEDICAL IN ITS SCAR RESPONSE: "THE HALF-PROCESSED PRODUCTS USED TO BE PROVIDED BY THE RAW MATERIAL SUPPLIER AS THROUGH PUT. NOW, PRODUCTS WERE MADE BY HAND STARTING FROM RAW MATERIAL COTTON. THEY WERE ROLLED UP TIGHT LAYER BY LAYER. IN ADDITION, MORE RIGOROUS INSPECTION PROCESS WAS IMPLEMENTED. EACH WORKER WILL RANDOMLY MAKE (B)(4) PRODUCTION SAMPLES. THE SAMPLES WILL BE MEASURED BASED ON SIZE AND WEIGHT (PLEASE SEE BELOW QUALITY ACCEPTANCE STANDARDS). IF THE WORKER PASSED THE INSPECTION, SHE WOULD CONTINUE THE MANUFACTURING PROCESS. IF NOT, THE WORKER WILL NEED TO SHOW COMPLIANCE WITH THE STANDARDS BEFORE SHE CAN START THE MANUFACTURING PROCESS. (B)(4). THE NEW INSPECTION TAKES EFFECT STARTING LOT NUMBER 61NK14 AND 61NL02 FOR ITEM NUMBER 641223 AS WELL AS LOT NUMBER 61NK13 FOR ITEM NUMBER 641225. " PREVENTIVE ACTION: GD MEDICAL IDENTIFIED IN ITS SCAR THAT IT IS SENDING A BUSINESS DEPARTMENT STAFF MEMBER TO THE LOCATION TO OBSERVE THE PROCESS TO ENSURE COMPLIANCE. THIS INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. DEVICE DISCARDED BY USER.

    Description of Event or Problem · 1

    SURGERY WAS DELAYED WHEN THE END USER REALIZED THE PRODUCT WAS LABELED INCORRECTLY. THE ITEM WAS THE WRONG SIZE - ONE HALF INCH WHEN IT SHOULD HAVE BEEN THREE-EIGHTS INCH. ADDITIONAL INFO WAS REQUESTED RELATED TO THE DELAY. THE SALES REPRESENTATIVE STATED IT WAS A MATTER OF MINUTES.

    Description of Event or Problem · 1

    SURGERY WAS DELAYED WHEN THE END USER REALIZED THE PRODUCT WAS THE WRONG SIZE -- ONE-HALF INCH WHEN IT SHOULD HAVE BEEN THREE-EIGHTHS INCH. ADDITIONAL INFORMATION WAS REQUESTED RELATED TO THE DELAY. THE SALES REPRESENTATIVE STATED IT WAS A MATTER OF MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156371 DOUBLE-STRUNG COTTON BALLS COTTON, ROLL EFN DEROYAL INDUSTRIES, INC. 36643960

    Patients

    Seq Age Sex Outcome Treatment
    1