BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERASEAL DUAL APPL 35CM R CE

    MDR report key: 19210536 · Received April 29, 2024

    Report

    Report Number
    2210968-2024-04954
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 14, 2024
    Manufacturer
    VIANT AS&O HOLDINGS INC.
    Product Code
    MZM
    PMA / PMN Number
    BK190324
    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). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. 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) H6. COMPONENT CODE: G07002 - 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. 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. PLEASE CLARIFY, WAS THE QUALITY ISSUE EXPERIENCED WITH THE VERASEAL DUAL APPLICATOR? OR WAS THE QUALITY ISSUE EXPERIENCED WITH THE LAPAROSCOPIC TIP VRAL35? IF THE PROBLEM WAS IN REGARDS TO THE LAPAROSCOPIC APPLICATOR (VRAL35), PLEASE PROVIDE CORRESPONDING LOT NUMBER AND CLARIFY IF IT IS AVAILABLE FOR EVALUATION. CAN YOU PLEASE ELABORATE ON HOW WAS THE TIP DAMAGED? DID YOU EXPERIENCE ANY CONNECTIVITY ISSUES? WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? EVENT RELATED TO MW (B)(4) 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 THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE NURSING STAFF STARTED TO REPLACE THE 35 CM TIP, BUT WHEN THEY TURNED IT AROUND, THE TIP WAS DAMAGED AND COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080486 VERASEAL DUAL APPL 35CM R CE FIBRIN SEALANT PREPARATION DEVICE MZM VIANT AS&O HOLDINGS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown