BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    MDR report key: 7670671 · Received July 9, 2018

    Report

    Report Number
    2210968-2018-74185
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059252
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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 Manufacturer Narrative · 1

    (B)(4). AN EMPTY OPEN FOIL, A WINDING FORMER WITH A UNDISPENSED SUTURE AND UNOPENED SAMPLES OF PRODUCT WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF SAMPLE, THE SUTURE END IS SEVERELY CUT (DAMAGED), RESULTING IN A CLIP OFF DEFECT. IN ADDITION, THE NEEDLE WAS NOT RETURNED FOR EVALUATION. PER THE SAMPLE CONDITION THE ASSIGNABLE CAUSE OF THE PERFORMANCE ¿ DAMAGED PRODUCT, IS A CLIP OFF DEFECT, THIS DEFECT IS CAUSED BY EXCESSIVE PRESSURE ON THE SUTURE DURING SWAGING OF THE NEEDLE AND CONSEQUENTLY BREAKING. UNOPENED REPRESENTATIVE SAMPLES WERE EXAMINED AND NO DEFECTS WERE FOUND ON THE PACKET. THE SAMPLES WERE OPENED AND THE SWAGE AND ATTACHMENT AREA WERE AS EXPECTED. THE SUTURES WERE EXAMINED ALONG OF STRAND AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE WERE ABOVE THE MINIMUM REQUIREMENTS. ACCORDING TO UNOPENED SAMPLES, NO ATTACHMENT DEFECTS WERE FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN ORAL AND DENTAL SURGERY ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING USE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514167 MONOCRYL POLIGLECAPRONE 25 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. LJM509 10705031059252

    Patients

    Seq Age Sex Outcome Treatment
    1