BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPASPHERE

    MDR report key: 24883905 · Received April 15, 2026

    Report

    Report Number
    9615728-2026-00054
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    May 7, 2024
    Report Date
    April 15, 2026
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    KRD
    PMA / PMN Number
    K172372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. CUSTOMER PROVIDED PHOTOGRAPHS DISPLAYED ALL LABELS SHOWING THE DATE OF MANUFACTURE AND THE EXPIRY DATE. THE PRINTING ON THE BOX LABELS WAS LESS LEGIBLE BECAUSE OF A BAD PRINT; HOWEVER, THE EXPIRY DATE IS ALSO PRINTED AT THE BOTTOM OF THE LABEL AND IS CLEAR AND LEGIBLE. THIS COMPLAINT HAS BEEN CONFIRMED. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKED LIKE 2026 INSTEAD OF 2025, HENCE THE HOSPITAL REJECTED AND RETURNED THE UNUSED PRODUCT TO DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65461 HEPASPHERE Device, Vascular, for Promoting Embolization KRD BIOSPHERE MEDICAL, S.A. X2519215-K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown