BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 18IN 6-0 S/A P-1 PRM

    MDR report key: 9335838 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90036
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059276
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE JJK598 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SUMMARY: IT WAS RECEIVED FOR ANALYSIS AN EMPTY OPENED FOIL, A PAPER LID AND A WINDING FORMER WITH A STUCK DETACHED NEEDLE AND A SUTURE IN SEVERAL PIECES OF PRODUCT CODE Y489, LOT JJK598. DURING THE VISUAL INSPECTION OF THE DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED AND REMNANT OF SUTURE WAS OBSERVED INSIDE BARREL HOLE. THE WINDING FORMER WAS VISUALLY EXAMINED, AND THE SUTURE COULD NOT BE DISPENSED SINCE HAS BEGUN WITH THE PROCESS OF DEGRADATION AND THIS CONDITION CAUSED THAT THE SUTURE WAS DETACHED OF THE NEEDLE. THE TIME OF EXPOSURE OF SUTURES TO THE ENVIRONMENT COULD NOT BE DETERMINED. ALSO, THE FOIL WAS EXAMINED AND SHOWED MULTIPLES WRINKLES AND HOLES IN CAVITY ON BOTTOM FOIL PACKET DUE TO EXCESSIVE MANIPULATION. PER THE CONDITION OF THE SAMPLES, THE ASSIGNABLE CAUSE OF PERFORMANCE DETACHED NEEDLE, IS SUTURE DEGRADATION; DUE TO THE IMPROPER HANDLING OF PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL AND ORAL SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE EVALUATION, THE PACKAGING FOIL SHOWED HOLES IN CAVITY ON THE BOTTOM. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131548 MCRYL UD 18IN 6-0 S/A P-1 PRM SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. JJK598 10705031059276

    Patients

    Seq Age Sex Outcome Treatment
    1