BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBABLE SURGICAL SUTURE USP

    MDR report key: 8583417 · Received May 6, 2019

    Report

    Report Number
    2210968-2019-81070
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 9, 2019
    Report Date
    April 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH MANUFACTURING RECORDS OF NW2493/T5014 REVIEWED FOR ANY PROCESS DEVIATION BUT NO DEVIATION WAS OBSERVED. FINISHED GOODS TESTS REPORTS WAS REVIEWED FOR TENSILE STRENGTH VALUE, NEEDLE PULL-OFF VALUE AND MOISTURE TEST RESULTS AND FOUND TO MEET THE SPECIFICATION REQUIREMENT.

    Additional Manufacturer Narrative · 0

    (B)(4). A COMPLAINT SAMPLE FOIL ALONG WITH A NEEDLE AND SBF FOLDER FOR CODE NW2493 LOT T5014. SUTURE RECEIVED IN COMPLETE DISINTEGRATED CONDITION. AS THE COMPLAINT SAMPLE RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION ON COMPLAINT SAMPLE CANNOT BE PERFORMED EXCEPT VISUAL INSPECTION. THE FOIL PACK WAS INSPECTED UNDER A 10 X MAGNIFICATION FOR ANY DAMAGE AND SHOWED A MULTITUDE OF WRINKLES OVER THE WHOLE FOIL ALONG WITH SEVERAL PINHOLES AT TOP LABEL SIDE AS WELL AS BOTTOM CAVITY SIDE OF THE PACKS WERE OBSERVED. RETURNED NEEDLE WAS INSPECTED UNDER 10X MAGNIFICATION AND FOUND SATISFACTORY. FIVE RETAIN SAMPLES OF INCIDENT CODE AND LOT NUMBER 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, AND SUTURES 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. 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 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 PERFORMANCE-PULL OFF SUTURE NEEDLE, NEEDLE PULL OFF TEST IS APPLICABLE & MEASURABLE PARAMETER. ALL THE INDIVIDUAL AS WELL AS AVERAGE NEEDLE PULL-OFF VALUES 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.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM SWAGE POINT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376541 ABSORBABLE SURGICAL SUTURE USP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. T5014

    Patients

    Seq Age Sex Outcome Treatment
    1