BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERISURE

    MDR report key: 23030773 · Received September 11, 2025

    Report

    Report Number
    3013145340-2025-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 11, 2025
    Manufacturer
    TERRAGENE S.A.
    Product Code
    JOJ
    UDI-DI
    07798375772259
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH'S DEVICE HISTORY RECORD SHOWED NO ANOMALIES. THE RETENTION SAMPLE FROM THE REPORTED BATCH WAS INSPECTED FINDING THAT IT WAS RELEASED IN ACCEPTABLE CONDITION. TO FURTHER SUPPORT THE EVALUATION, WE TESTED THE RETAINED SAMPLES TO TRY TO REPLICATE THE CONDITIONS REPORTED BY THE CUSTOMER. TERRAGENE FOUND NO LOSS OF STRUCTURAL INTEGRITY, NO SEAL COMPROMISE, AND NO ANOMALIES IN INK PERFORMANCE OR LABEL ADHESION. THE RESULTS OBTAINED BY THE CUSTOMER COULD NOT BE REPLICATED. NO REPORT OF INJURY OR DELAYS IN THE PROCESS. NO ADDITIONAL ISSUES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THEY USED AN VERISURE¿ STEAM TYPE 5 MIGRATING INTEGRATOR W/ EXTENDER (73155) AND, AFTER STERILIZATION, OBSERVED INK LEAKAGE (BLEEDING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365878 VERISURE CHEMICAL INDICATOR JOJ TERRAGENE S.A. VERISURE STEAM TYPE 5 MIGRATING INTEGRATOR W/ EXTENDER B40587 07798375772259

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown