BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 18IN 4-0 S/A PC-3 PRM MP

    MDR report key: 14885279 · Received July 1, 2022

    Report

    Report Number
    2210968-2022-05041
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059740
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNKNOWN: WAS THERE ANY PATIENT CONSEQUENCE REPORTED? HOW WAS THE PROCEDURE COMPLETED? DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? WHAT IS THE TOTAL NUMBER OF PROCEDURES? WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? WAS PROCEDURE SUCCESSFULLY COMPLETED? WERE FRAGMENTS GENERATED? IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? ANALYSIS SUMMARY: ONE EMPTY OPENED BOX, AND NINE SAMPLES OF PRODUCT CODE Y845 WERE RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICES. UPON VISUAL INSPECTION OF THE RETURNED SAMPLES, THE INFORMATION PRINTING ON THE FOILS OF THE NEEDLE, SHOWS A CONVENTIONAL CUTTING NEEDLE, SALES TYPE PC-3, NEEDLE LENGTH 16 MM, 3/8 CIRCLE. A FURTHER INVESTIGATION WAS PERFORMED, AND THE GRAPHICS USED IN EACH LOT NUMBER ARE CORRECT ACCORDING TO MANUFACTURING DATES AND FINISHED DRAWING. IN ADDITION, THE NEEDLE RMC ASSIGNED TO THESE LOTS NUMBER IS (NS-0508) NEEDLE SALES TYPE PC-3, 3/8 CIRCLE, CONVENTIONAL CUTTING, WIRE DIAMETER 18 MILS AND NEEDLE LENGTH 16 MM. THE NEEDLES WERE MEASURED IN DIAMETER AND MEET THE ETHICON REQUIREMENTS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE SIZE ON THE PACKAGING WAS 16MM, BUT THE SURGEONS BELIEVED THE NEEDLE WAS 13MM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231796 MCRYL UD 18IN 4-0 S/A PC-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y845G RPMCKT 10705031059740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown