BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD SPIKE PORT ADAPTOR CSTD

    MDR report key: 18902220 · Received March 13, 2024

    Report

    Report Number
    MW5152814
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 12, 2024
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS LEAKING BETWEEN THE CONNECTION OF THE ONGUARD SPIKE PORT ADAPTOR AND THE BAXTER PRIMARY TUBING 2R8875. THE LEAKING WAS OBSERVED BY THE PHARMACY TECHNICIAN WHO WAS PRIMING THE LINE WITH 0.9% SODIUM CHLORIDE. NO CHEMOTHERAPY LEAKED OUT. WE ISOLATED THE FAULTY SPIKE PORT ADAPTOR LOT AND HAVE NOT OBSERVED ANY FURTHER LEAKING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266787 ONGUARD SPIKE PORT ADAPTOR CSTD CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. UA3643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown