BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLU 60CM M0.4

    MDR report key: 17798003 · Received September 22, 2023

    Report

    Report Number
    2210968-2023-06990
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 1, 2023
    Report Date
    January 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/8/2024; H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED 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 THIRTEEN UNOPENED SAMPLES PERTAIN TO THE PRODUCT CODE KHH5662H. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE 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 AN INSTRON EQUIPMENT, THE PULL FORCE AND TENSILE FORCE WERE 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. 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. RELATED REPORTS: 2210968-2023-06987, 2210968-2023-06988, 2210968-2023-06989, & 2210968-2023-06990.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/22/2023. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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: PLEASE CONFIRM THE NUMBER OF DEVICES IN WHICH "NEEDLE CAME OFF THE THREAD," PLEASE CONFIRM THE NUMBER OF DEVICES IN WHICH "THREAD BROKEN SEVERAL TIMES." WHEN DID THE NEEDLE DETACH/PULL OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM THE PACKAGE, DURING HANDLING BEFORE USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY WHEN DID THE SUTURE BREAK (IN THE PACKAGE, DURING REMOVAL FROM THE PACKAGE, DURING HANDLING BEFORE USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY EVENT/PROCEDURE NAME AND DATE? PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) PLEASE PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN THE NOTES OR RMAO SECTIONS. 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: WHICH KID OF TISSUE WAS SUTURED? VEIN. AFTER HOW MANY TISSUE PASSAGES IS THE THREAD BROKEN? 2-3. IN RELATION TO THE NEEDLE, WHERE APPROXIMATELY DID THE THREAD BREAK? 5-10 CM. RELATED REPORTS: 2210968-2023-06987, 2210968-2023-06988, 2210968-2023-06989.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS FGA PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE THREAD, THREAD BROKEN SEVERAL TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353589 PROLENE BLU 60CM M0.4 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. SGMCAT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown