BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER (BLUNT) DISSECTOR

    MDR report key: 6067233 · Received October 31, 2016

    Report

    Report Number
    3010452421-2016-00021
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 6, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MEIXIN MEDICAL SUZHOU CO., LTD.
    Product Code
    EFQ
    PMA / PMN Number
    K831806
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: BASED ON THE EVALUATION OF THE COMPLAINT SAMPLE, THE ROOT CAUSE WAS DETERMINED TO BE A VENDOR RELATED ISSUE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). IN ITS RESPONSE, (B)(4) STATED THAT SOME EMPLOYEES DID NOT FULLY UNDERSTAND THE QUALITY REQUIREMENT FOR THE DISSECTORS AND FAILED TO REMOVE NONCONFORMING PRODUCT DEFECTED WITH THE REPORTED QUALITY ISSUE. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED THAT WORKERS HAVE BEEN RETRAINED ON THE QUALITY PRODUCT STANDARD. ADDITIONALLY, INSPECTION IS BEING PERFORMED OF THE OPERATION AT OUTPUT PRODUCT WORK SITES TO ENSURE CONFORMITY AND FULL INSPECTION OF FINISHED GOOD INVENTORY TO REMOVE NON-CONFORMING PRODUCT. INVESTIGATION SUMMARY MEDWATCH REPORT (B)(4) WAS RECEIVED REPORTING A KITTNER SPONGE (PART NUMBER 30-101, LOT NOT PROVIDED) CONTAINED A RADIOPAQUE THREAD THAT WAS SHREDDING FROM THE SPONGE WHEN IN USE. AN INTERNAL COMPLAINT (B)(4) WAS OPENED TO INVESTIGATE THIS REPORT. A LOT NUMBER WAS NOT REPORTED; THEREFORE, PROCESS RECORDS COULD NOT BE REVIEWED. A SAMPLE WAS RECEIVED NOVEMBER 4, 2016. THE SAMPLE WAS EVALUATED NOVEMBER 29, 2016, AFTER DECONTAMINATION. LOT NUMBER 42325989 WAS IDENTIFIED ON THE SAMPLE RECEIVED. INVENTORY EVALUATION WAS PERFORMED AND SHOWED SIMILAR ISSUES TO THE COMPLAINT SAMPLE. (B)(4) SUPPLIES THE DISSECTORS TO DEROYAL. THEREFORE, A SCAR WAS ISSUED TO (B)(4). THE RESPONSE WAS ACCEPTED DECEMBER 19, 2016. DURING MANUFACTURING FOR THE LOT NUMBER REFERENCED, THERE WERE (B)(4) FOAM HOLDERS THAT WERE DETECTED AS DEFECTIVE. THESE DEFECTIVE UNITS WERE REMOVED AND REPLACED WITH NEW INVENTORY. QUALITY CONTROL INSPECTION OF THE LOT NUMBER REFERENCED DOES NOT SHOW ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A TOTAL OF (B)(4) PACKS OUT OF (B)(4) TOTAL PACKS OF THE WORK ORDER WERE INSPECTED. A TOTAL OF (B)(4) PACKS OF THE PART IN REFERENCE HAVE BEEN SOLD FROM JANUARY 2, 2015, TO JANUARY 3, 2017. DURING THE SAME TIME FRAME, NO ISSUES OTHER THAN THE REFERENCED COMPLAINT HAVE BEEN REPORTED. NO OTHER FINISHED GOODS USING THE SAME RAW MATERIAL NUMBER HAVE REPORTED SIMILAR ISSUES. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY MEDWATCH REPORT (B)(4) WAS RECEIVED REPORTING A KITTNER SPONGE (PART NUMBER 30-101, LOT NOT PROVIDED) CONTAINED A RADIOPAQUE THREAD THAT WAS SHREDDING FROM THE SPONGE WHEN IN USE. AN INTERNAL COMPLAINT (CALL (B)(4)) WAS OPENED TO INVESTIGATE THIS REPORT. A LOT NUMBER WAS NOT REPORTED; THEREFORE, PROCESS RECORDS COULD NOT BE REVIEWED. A SAMPLE WAS REPORTED TO BE AVAILABLE; HOWEVER, AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN RECEIVED. EFFORTS ARE ONGOING TO RETRIEVE THE SAMPLE A TOTAL OF (B)(4) PACKS FOR THE REFERENCED PART NUMBER HAVE BEEN SOLD FROM 2014 TO PRESENT. A TOTAL OF (B)(4) INCIDENTS, INCLUDING THIS COMPLAINT, HAVE BEEN REPORTED FOR THE SAME TIME PERIOD. NO FINISHED GOODS UTILIZING THE SAME RAW MATERIAL SPONGE HAVE REPORTED SIMILAR ISSUES. THE RAW MATERIAL SPONGE IS SUPPLIED TO DEROYAL BY (B)(4). THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESC.: SURGEON NOTED RADIOPAQUE THREAD SHREDDING FROM KITTNER SPONGE WHEN IN USE. NOTE: REQUEST MADE FOR COMPANY REP CONTACT INFORMATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? THYROIDECTOMY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Description of Event or Problem · 1

    EVENT DESC.: SURGEON NOTED RADIOPAQUE THREAD SHREDDING FROM KITTNER SPONGE WHEN IN USE. NOTE: REQUEST MADE FOR COMPANY REP CONTACT INFORMATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? THYROIDECTOMY DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719742 KITTNER (BLUNT) DISSECTOR GAUZE/SPONGE, INTERNAL EFQ MEIXIN MEDICAL SUZHOU CO., LTD. 30-101 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR