BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ESWAB COLLECTION & TRANSPORT SYSTEM FOR AEROBIC, ANAEROBIC & FASTIDIOUS BACTE

    MDR report key: 25136350 · Received May 11, 2026

    Report

    Report Number
    25136350
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    COPAN INDUSTRIES, INC.
    Product Code
    JTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DR. IN THE [REDACTED] OB GYN CLINIC NOTICED THAT CERTAIN GBS [GROUP B STREPTOCOCCUS SWABS] SWABS ARE NOT OPENING AS EASILY AS THEY NORMALLY DO. OTHER PROVIDERS NOTED THAT THIS HAS BEEN HAPPENING FOR THEM AS WELL. IN REVIEWING THE SUPPLY ON HAND IN CLINIC, IT DOES APPEAR THAT LOT N5020566, 03061065-LOT N50196400 AND 0306689 LOT N 501185900 SEEM TO HAVE THE PLASTIC WRAPPER UPSIDE DOWN, SO THE EASIER PART TO OPEN IS AT THE BOTTOM AND NOT AT THE TOP AS INDICATED. PROVIDERS AND MY STAFF ARE HAVING TO USE SCISSORS AT TIMES TO OPEN THEM. IF OPENED FROM THE INCORRECT WAY ON THE BOTTOM, THIS PLACES RISK FOR CONTAMINATION OF THE SPECIMEN AS THE SWAB COULD BE COMPROMISED. THE PROVIDER REQUESTED THE REVIEW OF THE PRODUCTS IN QUESTION. NO PATIENTS HAVE BEEN IMPACTED THAT I AM AWARE OF. JUST PROVIDERS REPORTING THE CONCERN OF THE PRODUCT NOT WORKING AS IT NORMALLY HAS WHEN OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621826 BD ESWAB COLLECTION & TRANSPORT SYSTEM FOR AEROBIC, ANAEROBIC & FASTIDIOUS BACTE TRANSPORT SYSTEMS, ANAEROBIC JTX COPAN INDUSTRIES, INC. L. N50196400, N50185900, N5020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other