BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24971458 · Received April 23, 2026

    Report

    Report Number
    9611174-2026-00085
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Report Date
    May 6, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K000948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP EXHIBIT A PERFORATION IN THE TUBING AT THE PUMP LEVEL. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463466 MAJ-1682 ACCESSORY PORT TUBE WITH SALINE SPIKE - PK 10 OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10026686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown