BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVICEL DEVICE 1ML/2ML

    MDR report key: 15047434 · Received July 18, 2022

    Report

    Report Number
    3003183625-2022-00007
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    November 3, 2022
    Manufacturer
    TEL-HASHOMER
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS LEAKAGE DETECTED? IF YES, PLEASE CLARIFY WHERE DID THE LEAKAGE CAME FROM, DEVICE OR BIOLOGIC VIALS? DEVICE. WAS THE PRODUCT BROKEN? IF YES PLEASE CLARIFY WHICH COMPONENT OF THE KIT WAS BROKEN (BIOLOGICS VIALS OR APPLICATION DEVICE). APPLICATION DEVICE CUP IS BROKEN. 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?, H6. TYPE OF INVESTIGATION, H6. INVESTIGATION FINDINGS, H6. INVESTIGATION CONCLUSIONS 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?

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: G 6. COMPONENT CODE, G 6. TYPE OF INVESTIGATION, G 6. INVESTIGATION FINDINGS, G 6. INVESTIGATION CONCLUSIONS. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE DEVICES ARRIVED AND THE VIAL ADAPTOR HUBS WERE BROKEN AND LIQUID WAS FOUND IN THE RIGHT SYRINGE. ACCORDING TO THE MANUFACTURER THE ESTIMATION IS THAT THE USER DID NOT USE THE DEVICE PROPERLY. NO REPAIR WAS NEEDED; THE EVALUATOR ONLY ASSEMBLED NEW VIALS AND INJECTED THE FLUID AND THE DEVICE WORKED PROPERLY. 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: H3. DEVICE EVALUATED BY MANUFACTURER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE NURSE PERFORMED THE ASSEMBLY PROCEDURE AS NORMAL, THEN THE VIAL LOOSENED AND FELL OFF DURING DRAWING THE CONTENTS. THEY CHANGED TO A NEW SET OF FIBRIN SEALANT PREPARATION DEVICE IN THE OPERATION ROOM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320942 EVICEL DEVICE 1ML/2ML FIBRIN SEALANT PREPARATION DEVICE MZM TEL-HASHOMER 200088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown