BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPONGE PATTIE

    MDR report key: 4787351 · Received May 19, 2015

    Report

    Report Number
    1060680-2015-00038
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    March 17, 2015
    Report Date
    January 19, 2016
    Manufacturer
    CARWILD CORPORATION
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: PART NUMBER 30-058 IS SUPPLIED TO DEROYAL INDUSTRIES, INC. BY (B)(4). THE ACTUAL PRODUCT IS MANUFACTURED AT CARWILD'S FACILITY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). BECAUSE THERE WAS NO DETECTION OF THREAD ATTACHMENT FAILURES AND NO MATERIAL CHANGES HAVE BEEN MADE DURING THE PROCESS, IT WAS DETERMINED THE ROOT CAUSE IS NOT THE MANUFACTURING PROCESS. THE DESIGN OF THE PRODUCT IS THAT THE STRING IS AVAILABLE FOR LOCATION OF THE SPONGE (VERSUS SPONGES WITHOUT STRING); HOWEVER, THE STRING IS NOT MEANT TO BE USED TO REMOVE OR RELOCATE THE SPONGE IN SITU (THIS IS STATED IN THE IFU). THEREFORE, (B)(4) HAS STATED THE ROOT CAUSE FOR THE STRING DETACHMENT IS USUALLY ASSOCIATED WITH IMPROPER USE OF THE DEVICE BY USING THE STRING TO RELOCATE OR REMOVE THE DEVICE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: IN ITS SCAR RESPONSE, (B)(4) HAS STATED NO CORRECTION ACTION HAS BEEN IDENTIFIED TO BE REQUIRED AT THIS TIME. POST-MARKET EVALUATION WAS REVIEWED AND NO DEFECT RELATED TO THIS ISSUE WAS FOUND BY THE END OF 2014. NO ACTIONS WERE REQUIRED TO BE ADDED TO THE RISK ASSESSMENT EVALUATION ACCORDING WITH THE POST-MARKET RESULTS SPECIFIC FOR THIS TYPE OF DEFECT. MEDSORB DOMINICANA HAS INDICATED HEIGHTED AWARENESS OF THE DEFECT OCCURRENCE HAS BEEN DOCUMENTED AND PERSONNEL WORKING WITH THIS PRODUCT HAVE BEEN INFORMED. INVESTIGATION SUMMARY (B)(4) WAS RECEIVED REPORTING THAT THE STRING OF A NEURO PAD (PART NUMBER 30-058) IS DETACHING. BECAUSE THE PRODUCT IS SUPPLIED TO DEROYAL, A SCAR WAS ISSUED TO THE MANUFACTURER. IN ITS RESPONSE TO THE SCAR, MEDSORB DOMINICANA STATED THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBERS. NO ISSUES WERE FOUND RELATING TO THE STRING DETACHING DURING THE MANUFACTURING PROCESS. IN ITS SCAR RESPONSE, (B)(4) INDICATED THREAD ATTACHMENT IS EVALUATED 8 PIECES PER SONIC MACHINE AT THE BEGINNING OF EACH WORK ORDER AND THEN EACH HOUR TAKEN 8 PIECES PER THE SONIC MACHINE. THREAD ATTACHMENT MUST BE EQUAL TO OR GREATER THAN 1.0 LB FORCE. ALL DATA WAS FOUND TO BE BETWEEN 1.34-4.12 LBS IN LOT NUMBER 11A0113. ALL DATA WAS FOUND BETWEEN 1.33 AND 3.9 LBS IN LOT NUMBER 14A0079. (B)(4). PREVENTIVE ACTION: NO PREVENTIVE ACTION HAS BEEN TAKEN AT THIS TIME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE PRODUCT IS SUPPLIED TO DEROYAL BY (B)(4). (B)(4) ISSUED. THE DUE DATE IS 05/13/2015. FOLLOW UP WAS PERFORMED 05/14/2015 WITH THE VENDOR IN REFERENCE TO THE OUTSTANDING SCAR RESPONSE. INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED AS MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE STRING IS COMING OFF THE NEURO PAD CAUSING CONCERN THAT IT IS BEING LEFT IN THE BODY AS THE STRING IS NOT X-RAY DETECTABLE. THE DOCTOR WAS ABLE TO RETRIEVE THE PATTIES EVEN THOUGH THE STRING FELL OFF. AGAIN, THE CONCERN IS THE STRING WAS ON THE OPERATING ROOM FIELD AND IS NOT X-RAY DETECTABLE.

    Description of Event or Problem · 1

    THE STRING IS COMING OFF THE NEURO PAD CAUSING CONCERN THAT IT IS BEING LEFT IN THE BODY AS THE STRING IS NOT X-RAY DETECTABLE. THE DOCTOR WAS ABLE TO RETRIEVE THE PATTIES EVEN THOUGH THE STRING FELL OFF. AGAIN, THE CONCERN IS THE STRING WAS ON THE OPERATING ROOM FIELD AND IS NOT X-RAY DETECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324152 NEURO SPONGE PATTIE GAUZE/SPONGE, INTERNAL EFQ CARWILD CORPORATION 11A00113 14A0079

    Patients

    Seq Age Sex Outcome Treatment
    1