BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEO-LINK

    MDR report key: 778086 · Received December 22, 2004

    Report

    Report Number
    1419949-2004-00011
    Event Type
    Other
    Date Received
    December 22, 2004
    Date of Event
    November 24, 2004
    Report Date
    December 20, 2004
    Manufacturer
    VIASYS MEDSYSTEMS
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT RN NOTED SOME RESISTANCE AS SUCTION CATHETER INITIALLY INSERTED INTO NEO-LINK PORTHOLE. AS CATH WITHDRAWN, RN AND RCP "NOTICED PIECE OF MATERIAL AT END OF SUCTION CATH." CLINICIANS DISCONTINUED USE OF THIS ADAPTOR AND CATHETER. RCP REPORTS, "UPON FURTHER INVESTIGATION, IT OCCURRED TO ME, THAT IT WAS FROM DIAPHRAGM BECAUSE IT DID NOT LOOK INTACT AND THE VENT KEPT ALARMING BECAUSE IT COULDN'T MAINTAIN PRESSURE." NO ADVERSE SEQUELAE HAVE BEEN IDENTIFIED WITH THIS PATIENT RELATED TO THIS EVENT PER 12/13/04 F/U WITH RRT, MANAGER, RESPIRATORY CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-LINK CLOSED SUCTIONING ADAPTOR BZA VIASYS MEDSYSTEMS NA 13283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other