BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 24IN 8-0 D/A BV175-6 EP

    MDR report key: 18475193 · Received January 9, 2024

    Report

    Report Number
    2210968-2024-00240
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    January 1, 2023
    Report Date
    January 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031206809
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/30/2024. 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, FOUR UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE EP8741H. 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. 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: 2210968-2024-00239, 2210968-2024-00240, 2210968-2024-00241, 2210968-2024-00242, 2210968-2024-00243, 2210968-2024-00244, 2210968-2024-00245, 2210968-2024-00246.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 1/9/2024. H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. 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 INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT " 2-3 NEEDLES WERE NOT ABLE TO BE LOCATED WITHIN PATIENT/STERILE FIELD" * WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN THE NEEDLE POP OFF? THE CORONARY ARTERY * WERE X-RAYS TAKEN TO LOCATE THE NEEDLES? YES BUT THE NEEDLES ARE TOO SMALL TO FIND * DID ANY NEEDLE FALL IN THE PATIENT? IF YES, HOW WAS IT RETRIEVED? POSSIBLY. THEY COULDN¿T FIND 2-3 NEEDLES * IF RETAINED, WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? ARE THERE PLANS TO REMOVE IT IN THE FUTURE? THIS WAS NOT DISCUSSED * PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) ROSALIND MONAGHAN PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. I HAVEN¿T RECEIVED A SHIPPER KIT. THE NEEDLES WERE NOT SAVED. BUT I DO HAVE THE SUTURE THAT THEY DIDN¿T WANT TO KEEP USING FROM THE SAME LOT#/BOX A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. RELATED REPORTS: 2210968-2024-00239, 2210968-2024-00240, 2210968-2024-00241, 2210968-2024-00242, 2210968-2024-00243, 2210968-2024-00244, 2210968-2024-00245, 2210968-2024-00246

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 8 OF THE STRANDS THE NEEDLES KEPT POPPING OFF. THEY DECIDED TO NOT USE THE LOT NUMBER IT WAS PART OF. THEY GOT ANOTHER ONE TO COMPLETE THE CASE WITHOUT PATIENT HARM. 2-3 NEEDLES WERE NOT ABLE TO BE LOCATED WITHIN PATIENT/STERILE FIELD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554172 PRLNE BLU 24IN 8-0 D/A BV175-6 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. SEMHTX 10705031206809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown