BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NABS SUR SUT USP PROLENE* NW800

    MDR report key: 10851787 · Received November 17, 2020

    Report

    Report Number
    2210968-2020-09085
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 21, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/22/2020. H3 EVALUATION: DETAILED ANALYSIS OF RETAIN SAMPLE AGAINST COMPLAINT REPORTED. FIVE RETAIN SAMPLES OF INCIDENT CODES NW800 AND LOT NUMBER V8002 WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS AND NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS AND NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS AND NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR KNOT PULL TENSILE STRENGTH TEST AND FOUND TO MEET THE SPECIFICATION. ONE PHOTOGRAPH OF INTACT SUTURE UNIT CONTAINING BATCH DETAILS AS NW800 LOT V8002 RECEIVED FOR INVESTIGATION. UPON PRELIMINARY VISUAL INSPECTION PRODUCT FOUND TO BE GENUINE ETHICON MANUFACTURED PRODUCT. AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE BATCH RECORD REVIEW, IT HAS BEEN OBSERVED THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. AS THE COMPLAINT IS RELATED TO PERFORMANCE-BREAKAGE SUTURE, KNOT PULL TENSILE STRENGTH TEST IS APPLICABLE & MEASURABLE PARAMETER. KNOT PULL TENSILE STRENGTH TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SUTURE MATERIAL. THE AVERAGE KNOT PULL TENSILE STRENGTH VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE WITHIN SPECIFICATION AND MEET THE USP AVERAGE KNOT PULL TENSILE STRENGTH REQUIREMENT. ALL THE INDIVIDUAL AS WELL AS AVERAGE KNOT PULL TENSILE STRENGTH VALUES OF RETAIN SAMPLE WERE FOUND TO MEET THE USP SPECIFICATION REQUIREMENTS. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. HENCE, THIS COMPLAINT COULD NOT BE OBSERVED. THE REPORTED INCIDENT WAS ONE AND ISOLATED CASE FOR CODE NW800 LOT V8002. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PROCEDURE NAME? OPEN INGUINAL HERNIA CONFIRM PRODUCT CODE AND LOT NO. - NW800 LOT - V8002 MFD -4/ 2018, EXP3/2023 PATIENTS CONDITION? - GOOD AND GOT DISCHARGE WHAT WAS USED TO COMPLETE THE PROCEDURE? - NW800 WAS CODE WAS USED TO COMPLETE THE PROCEDURE BUT THE BATCH NUMBER WAS DIFFERENT DEVICE RETURN STATUS/FOLLOW UP? DUE TO SOME MISTAKE OF NURSING STAFF THE FOIL WAS IS MISPLACED & DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN INGUINAL HERNIA PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED AND ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT¿S STATUS IS GOOD AND GOT DISCHARGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318685 NABS SUR SUT USP PROLENE* NW800 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. V8002

    Patients

    Seq Age Sex Outcome Treatment
    1