BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25107459 · Received May 6, 2026

    Report

    Report Number
    1423395-2026-00113
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OES
    UDI-DI
    10198459078699
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TUBE WAS OBSERVED TO BE LEAKING AFTER PURGE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. BASED ON THE INFORMATION REVIEWED, THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. AN MDR SUBMISSION WAS REQUIRED AND HAS BEEN COMPLETED AND DOCUMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBE WAS OBSERVED TO BE LEAKING AFTER PURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399635 MEDLINE LEFT HEART SMGH-LF 2 OES MEDLINE INDUSTRIES, LP - SPT 25KBJ955 10198459078699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown