BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVFLO ROUTINE I-TAPED- BLUE 1000

    MDR report key: 23362929 · Received October 22, 2025

    Report

    Report Number
    1419341-2025-00036
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    August 21, 2025
    Report Date
    November 5, 2025
    Manufacturer
    XIAMEN VOKE MOLD & PLASTIC ENGINEER
    Product Code
    IDZ
    UDI-DI
    20849832022378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETAIN SAMPLES WERE NOT AVAILABLE FOR FURTHER TESTING. THE ROOT CAUSE FOR "THE PLASTIC SEEMS QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ACTIVFLO ROUTINE I-TAPED- BLUE 1000, P/N 39LC-500-2-L, LOT 20250307 SEEMED QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 15 OCT 2024 TO 15 OCT 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    ON 25 SEPTEMBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "THE PLASTIC SEEMS QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY." ON 18 OCTOBER 2025, THE LEICA ACCOUNT MANAGER ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 21 AUGUST 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229702 ACTIVFLO ROUTINE I-TAPED- BLUE 1000 CASSETTES, TISSUE IDZ XIAMEN VOKE MOLD & PLASTIC ENGINEER ACTIVFLO ROUTINE I-TAPED- BLUE 1000 20250307 20849832022378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown