BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1682 ACCESSORY PORT TUBE WITH SALINE SPIKE - PK 10

    MDR report key: 25308969 · Received May 27, 2026

    Report

    Report Number
    9611174-2026-00108
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 27, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K000948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OLYMPUS FLUSHING PUMP HAD A LEAKING TUBE. THE ISSUE WAS FOUND DURING AN INSPECTION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579388 MAJ-1682 ACCESSORY PORT TUBE WITH SALINE SPIKE - PK 10 K10026686 FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10026686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown