BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SU BOX FOR APPLICATION DEVICE 10ML FOR AUSTRALIA NEW ZEALAND

    MDR report key: 14693698 · Received June 15, 2022

    Report

    Report Number
    3003183625-2022-00004
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 18, 2022
    Manufacturer
    TEL-HASHOMER
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. WHAT LEAD TO THE LUER LOCK BREAKAGE? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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. DATE DEVICE RETURNED TO MANUFACTURER, D9. IS DEVICE RETURNED TO MANUFACTURER? H3 PHOTO INVESTIGATION SUMMARY: THE PICTURES THAT WERE PROVIDED WERE REVIEWED AND NO ANALYSIS OR CONCLUSION COULD BE MADE BASED ON THE DEPICTED IMAGES. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE ARRIVED BROKEN. THE DEVICE COULD NOT BE REPAIRED, THE PLASTIC IS COMPLETELY BROKEN. THEREFORE THERE WAS NO WAY TO PERFORM ANY TESTING ON THE DEVICE IN THE CONDITION IN WHICH IT WAS 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, 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. CORRECTED INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION?, H3. DEVICE EVALUATED BY MANUFACTURER?, H6. COMPONENT CODE, H6. TYPE OF INVESTIGATION, H6. INVESTIGATION FINDINGS, H6. INVESTIGATION CONCLUSIONS

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ¿ WHAT LEAD TO THE LUER LOCK BREAKAGE? WE ARE UNSURE, THINKING FAULTY LUER LOCK AS THE STAFF WAS WELL EXPERIENCED HAVING USED EVICEL FOR MANY CASES PRIOR. 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. CORRECTED INFORMATION: D7A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FIBRIN SEALANT PREPARATION DEVICE EXPERIENCED A MALFUNCTION, LEADING TO THE BREAKAGE OF THE LUER LOCKS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659428 SU BOX FOR APPLICATION DEVICE 10ML FOR AUSTRALIA NEW ZEALAND FIBRIN SEALANT PREPARATION DEVICE MZM TEL-HASHOMER 210004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown