BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN

    MDR report key: 16273482 · Received January 31, 2023

    Report

    Report Number
    2210968-2023-00665
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 31, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    UDI-DI
    10705031003552
    PMA / PMN Number
    CL I 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: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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 UNKNOWN 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. EVENTS REPORTED ON: MW# 2210968-2023-00664. 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). H3 EVALUATION: ONE USED COMPLAINT SAMPLE OF DRAIN WAS RECEIVED FOR EVALUATION, DURING VISUAL INSPECTION, SOME CUT MARK WAS OBSERVED ON THE DRAIN, WHICH MIGHT LEAD THE DECREASED DRAINAGE VOLUME. AS PER STANDARD PRACTICE, THERE IS NO GENERATION POINT OF SUCH DEFECT DURING THE PRODUCTION. ALSO, 100% INSPECTION WAS CARRIED OUT, VISUAL. BEFORE AND AFTER PACKING OF FINISHED GOODS, PRIOR TO THE PRODUCT RELEASE. SO, THERE WAS NO SCOPE AT MANUFACTURER END TO MISS SUCH DEFECT, AT MANUFACTURING / RELEASE STAGE. DURING INVESTIGATION OF THE COMPLAINT, BATCH MANUFACTURING RECORD AND RETAINED SAMPLE REVIEW COULD NOT PERFORMED, AS THE LOT NUMBER OF THE COMPLAINT WAS UNKNOWN. IT IS SUSPECTED THAT, THE CRACKED AREA OF THE DRAIN MIGHT HAVE COME IN CONTACT WITH SOME SHARP TOOL USED DURING SURGERY, AND LEAD TO THE DEFECT GENERATION. EXTERNAL FACTORS LIKE MISHANDLING OR IMPROPER USAGE AT USER END COULD NOT BE RULED OUT. THEREFORE, FURTHER INVESTIGATION OF THE RECEIVED SAMPLES IS NOT POSSIBLE, AS THESE FACTORS ARE OUT OF SCOPE. 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 DRAIN WAS USED. IN THE WARD / ICU, DRAINS WERE PLACED. AT 17:00 ON (B)(6), 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 (B)(6), DECREASED DRAINAGE VOLUME WAS CONFIRMED AND ONE DRAIN WAS REMOVED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851231 BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN CATHETER, IRRIGATION GBX ETHICON INC. 2227 10705031003552

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown