BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET NERIA GUARD 60CM 9MM

    MDR report key: 24033236 · Received January 12, 2026

    Report

    Report Number
    MW5182007
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 6, 2026
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS/COVATEC, INC./UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT REPORTS EXPERIENCING DIARRHEA, HEADACHE, JAW PAIN, HYPOTENSION/ LOW BLOOD PRESSURE, RASH AND (UNSPECIFIED) STOMACH ISSUES SINCE THEIR LAST FILL. PT ALSO REPORTS EXPERIENCING DIZZINESS. PT REPORTS THEY EXPERIENCED ALL THESE SYMPTOMS IN THE HOSPITAL BUT MILDER IN INTENSITY. REASON(S), DATE(S) OF ADMITTANCE AND DISCHARGE, OR LENGTH OF HOSPITALIZATION IS UNKNOWN. PT ALSO REPORTS DEFECTIVE INFUSION SET NERIA GUARD LOT NUMBER 6012562. PT REPORTS THAT YESTERDAY (B)(6) 2026 THEIR PUMP KEPT BEEPING WITH AN OCCLUSION ALARM AND THERE WAS NO OCCLUSION, BUT A LEAK IN THE INFUSION SET WHICH PT REPLACED. IT IS UNKNOWN IF THE PT EXPERIENCED ANY ADVERSE EVENTS OR AN INTERRUPTION IN THERAPY DUE TO TUBING ISSUE. IT IS UNKNOWN IF THE INFUSION SET IS AVAILABLE FOR RETURN. NO FURTHER INFO, DETAILS, OR DATES AVAILABLE. CURRENT REMODULIN DOSE: 22.52NG/KG/MIN. SQ REMUNITY SELF-FILL PT VIA REMUNITY PRO PUMP. PT STARTED USING REMUNITY PRO DEVICE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107460 INF SET NERIA GUARD 60CM 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA INTRA PUMP INFUSION SYSTEMS/COVATEC, INC./UNOMEDICAL A/S 6012562

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female REMODULIN.