BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 23858540 · Received December 20, 2025

    Report

    Report Number
    3004824601-2025-00243
    Event Type
    Malfunction
    Date Received
    December 20, 2025
    Date of Event
    March 25, 2025
    Report Date
    December 18, 2025
    Manufacturer
    CITOTEST LABWARE MANUFACTURING CO.,
    Product Code
    KJG
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT THE EVENT RESULTED IN A SERIOUS INJURY. HOWEVER, THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ASP GLOBAL, IN COLLABORATION WITH ITS CONTRACT MANUFACTURER, COMPLETED THE INVESTIGATION FOR THIS COMPLAINT. THE INVESTIGATION INDICATED THAT THE RAW MATERIAL RESIN MAY NOT BE SUITABLE FOR REPETITIVE USE. AS A RESULT, A PRODUCT CHANGE WAS INITIATED TO EVALUATE AND IMPLEMENT AN ALTERNATIVE RESIN TYPE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED THAT PATIENTS WERE EXPERIENCING FINGER PAIN WHILE USING CHB3035-82 TOP SNAP CAP DUE TO THE CAPS BEING HARD TO FIT ON THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344457 CARDINAL HEALTH SNAP CAPS KJG CITOTEST LABWARE MANUFACTURING CO., CHB3035-82 230522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown