BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 8913296 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85869
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH MANUFACTURING RECORDS OF MNW6555/V6004 WAS REVIEWED FOR ANY PROCESS DEVIATION BUT NO DEVIATION WAS OBSERVED. FINISHED GOODS TESTS REPORTS WERE REVIEWED FOR TENSILE STRENGTH VALUE, NEEDLE PULL-OFF VALUE, MOISTURE TEST RESULTS AND TEFLON DIMENSIONS FOUND TO MEET THE SPECIFICATION REQUIREMENT. ADDITIONAL INVESTIGATION SUMMARY: 01 OPENED COMPLAINT SAMPLE UNITS WAS RECEIVED ALONG WITH SUTURE, NEEDLE AND SBF FOR CODE MNW6555 LOT V6004. SINCE THE COMPLAINT SAMPLE WAS RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION ON COMPLAINT SAMPLE COULD NOT BE PERFORMED EXCEPT VISUAL INSPECTION. RETURNED SUTURE WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND OBSERVED THAT CONTACT WITH A SHARP OBJECT / INSTRUMENTS DURING HANDLING AT MULTIPLE PLACES COULD HAVE RESULTED IN SUTURE BREAKAGE. SUTURE FRAYING WAS OBSERVED AT BROKEN SUTURE TIP LEADING TO POLYESTER BRAIDING SEPARATION WHICH INDICATED THAT SUTURE MIGHT GOT CUT BY SHARP INSTRUMENT. PLEDGET WAS NOT RETURNED FOR INVESTIGATION. RETURNED NEEDLE WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND FOUND SATISFACTORY. RETAINED SAMPLE EVALUATION: ONE INTACT RETAINED SAMPLE POUCH (CONTAINING 05 WHITE & 05 GREEN SUTURES) OF INCIDENT CODE MNW6555 AND LOT V6004 WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, SUTURES, PLEDGET AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR NEEDLE PULL TEST AND FOUND TO MEET THE SPECIFICATION. PLEDGET WERE VISUALLY INSPECTED FOR ITS APPEARANCE AND FOUND SATISFACTORY. RETAINED SAMPLE EVALUATION INDICATED THAT THE PRODUCT IS NOT HAVING ANY MANUFACTURING DEFECT. 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 AND PLEDGET DIMENSION AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE ABOVE ANALYSIS, IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. AS THE COMPLAINT IS RELATED TO BREAKAGE SUTURE, KNOT PULL TENSILE STRENGTH TEST IS APPLICABLE & MEASURABLE PARAMETER. ALL THE INDIVIDUAL AS WELL AS AVERAGE KNOT PULL TENSILE STRENGTH VALUES WERE FOUND TO MEET THE USP SPECIFICATION REQUIREMENTS. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 9/19/2019.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH MANUFACTURING RECORDS OF MNW6577/V6004 WAS REVIEWED FOR ANY PROCESS DEVIATION BUT NO DEVIATION WAS OBSERVED. FINISHED GOODS TESTS REPORTS WERE REVIEWED AND FOUND TO MEET THE SPECIFICATION REQUIREMENT. ATTEMPTS ARE BEING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MITRAL VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FROM THE SEWAGE POINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SET OF SUTURES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706802 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. V6004

    Patients

    Seq Age Sex Outcome Treatment
    1