BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC*RESV. 150 ML

    MDR report key: 16273479 · Received January 31, 2023

    Report

    Report Number
    2210968-2023-00664
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    December 27, 2022
    Report Date
    April 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    JOL
    PMA / PMN Number
    CL II EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: -ONLY THE 10FR DRAIN WAS TAPED AND THERE WERE NO OTHER FUNCTIONAL DEFECTS. -NO ADDITIONAL TREATMENTS WERE PERFORMED OTHER THAN REMOVAL OF THE DRAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY, WERE THERE ANY ISSUES WITH THE BLAKE DRAINS (2227 10 FR AND UNKNOWN 15 FR BLAKE DRAIN)? IF YES, PLEASE DESCRIBE DRAINAGE COULD NOT BE PERFORMED PROPERLY. ¿ WHAT IS THE PRODUCT CODE OF THE UNKNONW 15FR BLAKE DRAIN USED? UNK. ¿ WHAT IS THE LOT NUMBER OF EACH DRAIN? 10FR IS (JU0683RESERVOIR), 15FR LOT NUMBER IS UNKNOWN. ¿ WHY WAS THE 2227 BLAKE DRAIN REMOVED? WAS THE DRAIN NOT WORKING PROPERLY? SINCE THE DRAINAGE OF FLUID WAS DECREASED. ¿ PLEASE CLARIFY, DID THE ISSUE CAME FROM THE DRAINS OR FROM THE JVAC RESERVOIR 2177? DRAINS ¿ PLEASE CLARIFY WHICH DEVICES WILL BE RETURNED FOR EVALUATION? 10FR ¿ PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED." THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. EVENTS REPORTED ON: MW# 2210968-2023-00665. 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, 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). ADDITIONAL INFORMATION: D9 H3 EVALUATION: PRODUCT SAMPLE RECEIVED FOR ANALYSIS. MATERIAL LOCKING MECHANISM OF RESERVOIR WAS CHECKED TO VERIFY ITS CONDITION. SAMPLE WAS EVALUATED, AND DURING THIS EVALUATION IT WAS NOTICE THAT THE LATCH OF PLATE AND ITS MECHANISM WERE IN GOOD CONDITION. PLATE WAS ABLE TO BE OPEN AND CLOSED WITH NO ISSUED OBSERVED. IN ADDITION, PLATE SUBASSEMBLY NEEDS TO BE PROPERLY CLOSED IN ORDER TO PERFORM FINAL ASSEMBLY ON FINISH GOOD. THEREFORE, IS CONSIDERED THIS MATERIALS FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. MAN IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) FOR THIS MEDICAL DEVICE, THIS IS A SUCTION RESERVOIR, AND IT IS DESIGNED TO EVACUATE POTENTIALLY DETRIMENTAL COLLECTION OF CERTAIN FLUIDS FROM WOUNDS IN BODY CAVITIES THOUGH ITS MECHANISM OF SUCTION. THEREFORE, IN ORDER TO HAVE A PROPER FUNCTIONALLY AND FOR THE CORRECT ACTIVATION OF THIS SUCTION RESERVOIR IT IS NECESSARY THAT AFTER DRAIN TUBING IS CONNECTED TO THE PORT, START THE SUCTION BY GENTLY BENDING UP THE BOTTOM FLAP, THE UNIT WILL RELEASE, AND SUCTION WILL BEGIN, IN ADDITION, AN AIRTIGHT SEAL BETWEEN ALL SYSTEM COMPONENTS (DRAIN, ADAPTER, AND RESERVOIR) IS NECESSARY FOR PROPER SYSTEM FUNCTION. TO DEVIATE THE GIVEN INDICATIONS IS CONSIDERED AN INADEQUATE USAGE OF THIS SUCTION RESERVOIR. THEREFORE, IT IS CONSIDERED THAT THIS MAN FACTOR COULD HAVE AFFECTED THE PRODUCT INTEGRITY AND ITS FUNCTION. MACHINE WELDING AROUND THE PORTS AND IN THE PERIMETER OF THE BAG WAS INSPECTED AND IT WAS IN GOOD CONDITION, THERE WAS NO PRESENCE OF WEAK WELDING OR OVER WELDING THAT COULD CAUSE A LEAKAGE. THE RESERVOIR WAS ACTIVATED WHILE THE CAPS WERE INSERTED ON THE PORTS EXPECTING THAT NO AIR WILL GO INTO THE RESERVOIR, THEN, THE BAG DID NOT INFLATE. IT MEANS THAT THERE IS NO DAMAGE ON THE FILM OF THE RESERVOIR. THEREFORE, IT IS CONSIDERED THAT MACHINE FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. METHOD RESERVOIR DIDN'T PRESENT ANY DAMAGE OR TEARS ON THE FRONT OR THE BACK SIDE. PLATE WAS ACTIVATED, PORT CLOSED, AND THE SWELLED RESERVOIR WAS PRESSED TO VERIFY IF THERE COULD BE ANY VISIBLE LEAK. NO LEAK COULD BE IDENTIFIED. THEREFORE, IS CONSIDERED THIS METHOD FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. BASED ON THE PRESENT ANALYSIS, AND CONDITION OF SAMPLE RECEIVED IT IS DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IT IS NOT RELATED TO MANUFACTURING PROCESS AND OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE MANUFACTURING CONTROL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A BREAST CANCER SURGERY ON (B)(6) 2022 AND A RESERVOIR WAS USED. IN THE WARD / ICU, DRAINS WERE PLACED. AT 17:00 ON JANUARY 2, A HOSPITAL STAFF NOTICED THAT NO NEGATIVE PRESSURE WAS APPLIED AND REPORTED IT TO THE SURGEON, WHO INSTRUCTED TO REINFORCE THE PRODUCT CRACK WITH TAPE. AT 9:00 ON JANUARY 4, DECREASED DRAINAGE VOLUME WAS CONFIRMED AND ONE DRAIN WAS REMOVED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851228 J-VAC*RESV. 150 ML CATHETER AND TIP SUCTION JOL ETHICON INC. JU0683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown