BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS+ VIO 27IN 4-0 S/A RB-1

    MDR report key: 17090547 · Received June 8, 2023

    Report

    Report Number
    2210968-2023-04190
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 29, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031047976
    PMA / PMN Number
    K061037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. TRADE NAME: IRGACARE®. ACTIVE INGREDIENT(S): TRICLOSAN. DOSAGE FORM: SUTURE/SOLID/PARENTERAL. STRENGTH: = 2360 G/M. RELATED EVENTS CAPTURED VIA 2210968-2023-04188, 2210968-2023-04189, 2210968-2023-04191.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/28/2023. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED SIXTY-EIGHT UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE PDP304H. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, AND NO DEFECTS WERE FOUND ON THE PACKAGES. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO ISSUES RELATED TO BREAKAGE SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. ALSO, A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. RELATED EVENTS CAPTURED VIA 2210968-2023-04188, 2210968-2023-04189, 2210968-2023-04190, 2210968-2023-04191.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BILIARY RECONSTRUCTION SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER THREE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468661 PDS+ VIO 27IN 4-0 S/A RB-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. PDP304H RGMPBL 10705031047976

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown