BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 6-0 D/A BV

    MDR report key: 18841273 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02456
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 12, 2024
    Report Date
    May 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031020481
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/24/2024. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED SIXTEEN UNOPENED THAT PERTAIN TO PRODUCT CODE 8776H. AFTER VISUALLY INSPECTING THE RETURNED SAMPLES, IT WAS FOUND THAT TWELVE SAMPLES HAD AN INCORRECT SWAGE. THE MARKS IN THE SWAGE AREA WERE NOT AS EXPECTED, CAUSING A PULL OFF IN TWO NEEDLE SUTURE COMBINATIONS. IN THE REMAINING FOUR SAMPLES THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. ADDITIONALLY, THE SUTURE WAS EXAMINED, AND THE INSERTION MARK COULD BE OBSERVED IN THE EXTREMES OF THE SUTURES. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE DID NOT MEET THE MINIMUM REQUIREMENTS ON TWO SAMPLES. IN THE OTHER FOURTEEN SAMPLES, THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, AN INCORRECT SWAGE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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.

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. - IT WAS REPORTED THE NEEDLES TEAR OFF THE SUTURE. WHAT IS THE TOTAL NUMBER OF PRODUCTS INVOLVED IN THIS EVENT? A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED RELATED EVENTS CAPTURED VIA: 2210968-2024-02457.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024; AND A SUTURE WAS USED. THE NEEDLE TORE OFF THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476815 PRLNE BLU 30IN 6-0 D/A BV SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TGBKPZ 10705031020481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown