BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXAL

    MDR report key: 22714131 · Received August 5, 2025

    Report

    Report Number
    22714131
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    June 15, 2025
    Report Date
    July 24, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDINAL HEALTH NITRILE EXAM GLOVES ALL HAVE A "GASOLINE' OR CHEMICAL TYPE SMELL IN THE BOX. HAVE BEEN NOTICING THIS FOR A WHILE SO IT ISN'T A NEW THING. PREVIOUS GLOVES DID NOT HAVE THIS SMELL BUT ALSO CAME OUT IN CLUMPS OR TORE WHEN BEING WORN. CARDINAL CAME ON SITE AND CONFIRMED THE SMELL IS APPARENT IN OUR CARE UNITS. THEY HAVE SAMPLES TO INVESTIGATE. NOT LOT SPECIFIC. ALL SIZES IMPACTED. CARDINAL HAS OPENED AN INVESTIGATION WITH THEIR MANUFACTURER OVERSEAS. PRODUCTS: REFS: 88FS05XL, 88FS04L, 88FS03M, 88FS02S. MANUFACTURER RESPONSE FOR NITRILE EXAM GLOVE, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804230 FLEXAL PATIENT EXAMINATION GLOVE, SPECIALTY LZC CARDINAL HEALTH 200, LLC 88FS05XL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown