BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAPIDE SUTURE

    MDR report key: 7916238 · Received September 27, 2018

    Report

    Report Number
    2210968-2018-76121
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: WE RECEIVED 1 EA OF COMPLAINT SAMPLE FOIL, SBF FOLDER SUTURE PIECES CODE (B)(4). SUTURE RECEIVED IN 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. FIVE RETAIN SAMPLES OF INCIDENT CODES AND LOT NUMBER WAS 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 KNOT PULL TENSILE 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 ¿ 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 MEET THE IN-HOUSE AVERAGE KNOT PULL TENSILE STRENGTH REQUIREMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    A DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION SHOWED A MULTITUDE OF WRINKLES OVER THE WHOLE FOIL. SEVERAL PINHOLES AT TOP LABEL SIDE AS WELL AS BOTTOM CAVITY SIDE OF THE PACKS WERE OBSERVED. THIS DEVICE WAS NOT USED ON A PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754500 VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. T7001

    Patients

    Seq Age Sex Outcome Treatment
    1