BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 24IN 7-0 D/A BV175-6 EP

    MDR report key: 18676874 · Received February 9, 2024

    Report

    Report Number
    2210968-2024-01208
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031206786
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT: (B)(4). H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, NINE UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE EP8735H. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. 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 THE STRAND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 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. 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. WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? - DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE CUSTOMER THAT THE NEEDLE WAS COMING OFF WITH THE EVERPOINT SUTURE WITHOUT MUCH TENSION BEING DONE AFTER A FEW PASSES THROUGH TISSUE ON THE DISTAL ANASTOMOSIS INVOLVED WITH LOT NUMBER TEBEPP. SURGEON WANTS TO SEND BACK IMPACTED LOT IN EXCHANGE FOR ANOTHER ONE. REP ONLY HAS SAMPLES TO RETURN BUT NOT THE ACTUAL IMPACTED PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59878 PRLNE BLU 24IN 7-0 D/A BV175-6 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. TEBEPP 10705031206786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown