BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 14787048 · Received June 23, 2022

    Report

    Report Number
    2210968-2022-04783
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: WHAT IS THE LOT NUMBER? DO NOT HAVE THE LOT NUMBER. PLEASE SPECIFY WHICH PART OF THE DEVICE WAS BROKEN (PRE-FILLED SYRINGE OR THE DUAL APPLICATOR TIP)? WE BELIEVE THE RIGHT LURE LOCK MAY HAVE EVEN TIGHTENED TO TIGHT HENCE THE RIGHT SIDE HAD PRODUCT LEAKING OUT. WAS THE PRODUCT FOUND TO BE BROKEN INSIDE ITS PACKAGING? NOT SURE. OR WAS THE PRODUCT BROKEN WHILE IN USE? WHEN GOING TO USE, THE ISSUE WAS NOTICED. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO AND THE PRODUCT WASN¿T SAVED TO SEE THE DEVICE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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 A GASTRIC BYPASS PROCEDURE ON (B)(6) 2022 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THE APPLICATOR WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264853 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown