BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE COUNTER

    MDR report key: 4942287 · Received July 23, 2015

    Report

    Report Number
    3004605321-2015-00015
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 22, 2015
    Report Date
    September 23, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: WHEN THE REPORT WAS RECEIVED, IT WAS DETERMINED THAT A JOINT INVESTIGATION WITH THE MFG PLANT (B)(4) WOULD BE REQUIRED. THE CALL WAS FORWARDED TO THE PLANT'S REP. THE QC COMPLAINT SPECIALIST EVALUATED THE RETURNED SAMPLE. THE LOT NUMBER IDENTIFICATION WAS NOT AVAILABLE. YELLOW FOAM CUTOUT WITH BLACK WRITING THAT IS NOT PART OF THE ORIGINAL PRODUCT WAS DISCOVERED INSIDE THE RETURNED SAMPLE. VISUAL EXAMINATION OF THE PRODUCT DID NOT SHOW A WHITE POWDER. WHEN THE MAGNET SURFACE WAS RUBBED WITH A GLOVED FINGER (POLYVINYL NON-POWDER GLOVE), A WHITE POWDER APPEARED. RUBBING THE SURFACE APPEARED TO SCRAPE OFF A THIN FILM ON THE SURFACE OF THE MAGNET. VIA ADD'L COMMUNICATION WITH THE REPORTING CUSTOMER, THEY HAVE IDENTIFIED THE "WHITE POWDER" AS STRONTIUM CHLORIDE. REQUESTS HAVE BEEN MADE TO OBTAIN THE REPORTING CUSTOMER'S TEST METHODS AND DOCUMENTATION, BUT THE INFO HAS NOT BEEN RECEIVED AS OF (B)(4) 2015. THE LOT NUMBER INITIALLY REPORTED WAS INCOMPLETE AND, THEREFORE, INVALID. FOLLOWING ADD'L COMMUNICATION WITH THE REPORTING CUSTOMER, THE CORRECT LOT NUMBER WAS IDENTIFIED VIA EMAIL ON (B)(4) 2015. LOT MAPPING OF THE PRINTED MAGNET SHEEP PART (#01056). WORK ORDERS FROM THE (B)(4) PLANT SHOW THAT THE LOT NUMBER, 35891501, OF PRINTED MAGNET SHEET (01056) WAS USED IN THE MFG OF THE TWO POTENTIAL LOTS FOR PART #(B)(4) LISTED ABOVE. THE PRINTED MAGNET SHEET IS PREPARED AT (B)(4) CONVERTING. THE MAGNET SHEETS (10570) ON A ROLL ARE CUT AND PRINTED WITH WATER SOLUBLE INK (#3-15143). THE PRINTED MAGNET SHEET COMPONENTS WERE OBTAINED FROM THE SDS. REFER TO THE 3-5143 FILM X-CEL WHITE TONER AND 659745 - MATERIAL SAFETY DATA SHEET ATTACHMENTS. THE FILM X-CEL WHITE TONER (3-5143) COMPONENTS ARE TITANIUM OXIDE, MODIFIED STYRENE ACRYLIC COPOLYMER, STYRENE MALIC ANHYDRIDE RESIN, AND ISOPROPANOL. THE MAGNET (10570) COMPONENTS ARE FERRITE POWDER, POLYMER BINDER, VINYL ACETATE, AND BARIUM. THE WORK ORDER FOR THE 01056 MAGNET SHEET WAS REVIEWED AND FOUND TO CONTAIN RAW MATERIAL 10570, LOT NUMBER 18620. THE VENDOR FOR THIS COMPONENT IS (B)(4). A REQUEST WAS SUBMITTED TO (B)(4) SUPPLY CHAIN ON (B)(4) 2015 TO CONTACT THE VENDOR AND INQUIRE WHETHER ITS MFG PROCESS WOULD PRODUCE OR INCLUDE STRONTIUM CHLORIDE. ATTEMPTS TO OBTAIN CLARIFICATION FROM THE REPORTING CUSTOMER AS TO WHETHER THE "WHITE POWDER" MADE CONTACT WITH THE PT. AS OF (B)(4) 2015, THIS CLARIFICATION HAS NOT BEEN RECEIVED. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: A TRUE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED AT THE PRESENT TIME. THE INVESTIGATION IS ONGOING. SAMPLES WERE RECEIVED FOR EVAL AND AN UNK CONTAMINATION HAS BEEN CONFIRMED. CORRECTION ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE ONGOING INVESTIGATION STATUS, A CORRECTIVE ACTION HAS NOT BEEN TAKEN AT THE PRESENT TIME. PREVENTIVE ACTION: DUE TO THE ONGOING INVESTIGATION STATUS, A CORRECTIVE ACTION HAS NOT BEEN TAKEN AT THE PRESENT TIME. PREVENTIVE ACTION: DUE TO THE ONGOING INVESTIGATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN AT THE PRESENT TIME. THIS INVESTIGATION IS INCOMPLETE. THE REPORT WILL BE UPDATED AS MORE INFO BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE DEROYAL QUALITY CONTROL SPECIALIST CONTACTED THE REPORTING CUSTOMER, KAWAMOTO CORPORATION, TO CLARIFY THE STATEMENT, "I HEARD FROM SALES THAT THE POWDER FELL ON THE INTERNAL ORGANS IN THE LAPAROTOMY OPERATION AND THE MEDICAL STAFF HAD TO CLEAN AND WASH." KAWAMOTO CORPORATION RESPONDED CONFIRMING THAT THE PRODUCT DID NOT HAVE PATIENT CONTACT. THE WHITE POWDER FOUND ON THE MAGNET WAS IDENTIFIED AS STRONTIUM CHLORIDE. THE REPORTING CUSTOMER CONDUCTED INFRARED SPECTROSCOPY, FLUORESCENT X-RAY SPECTROSCOPY, AND X-RAY DIFFRACTOMETRY TESTS TO VERIFY THIS. THE RESULTS OF THIS TESTING ARE ATTACHED TO THIS REPORT. ROOT CAUSE ANALYSIS: THE TRUE ROOT CAUSE WAS DETERMINED TO BE THE CHEMICAL COMPOSITION OF THE MAGNET AND ATOMOSPHERIC CONDITIONS. STRONTIUM CHLORIDE WAS IDENTIFIED TO BE THE WHITE POWDER ON THE MAGNET. STRONTIUM IS USED IN THE FERRITE POWDER THAT FLEXMAG INDUSTRIES UTILIZES TO MANUFACTURE THE MAGNET. IF/WHEN THE MANGNET IS IN CONTACT WITH WATER/HUMIDITY, SMALL AMOUNTS OF THE STRONTIUM CAN LEACH TO THE SURFACE AND WILL PICK UP FREE CHLORINE IN THE ATMOSPHERE TO FORM STRONTIUM CHLORIDE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE ANALYSIS, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE ANALYSIS DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    WHITE POWDER WAS FOUND ON THE MAGNET INSIDE THE NEEDLE COUNTER. INCIDENT OCCURRED DURING THE MIDDLE OF A LAPAROTOMY PROCEDURE. THE MEDICAL STAFF HAD TO CLEAN AND WASH.

    Description of Event or Problem · 1

    WHITE POWDER WAS FOUND ON THE MAGNET INSIDE THE NEEDLE COUNTER. INCIDENT OCCURRED DURING THE MIDDLE OF A LAPAROTOMY PROCEDURE. THE MEDICAL STAFF HAD TO CLEAN AND WASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481190 NEEDLE COUNTER INSTRUMENT, SURGICAL, PROCEDURE KDC DEROYAL INDUSTRIES, INC. 36343460

    Patients

    Seq Age Sex Outcome Treatment
    1