BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CATHETER

    MDR report key: 21803 · Received April 19, 1995

    Report

    Report Number
    21803
    Event Type
    Malfunction
    Date Received
    April 19, 1995
    Date of Event
    April 2, 1995
    Report Date
    April 12, 1995
    Manufacturer
    SUPERIOR HEALTHCARE GROUP, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING THE PACKAGE OF A "SUCTION CATHETER KIT" AND ATTEMPTING TO USE IT TO SUCTION A PT'S ENDOTRACHEAL TUBE, THE NURSE NOTICED CUTS IN THE CATHETER. DURING SUCTIONING THE CATHETER IS INSERTED THROUGH THE ENDOTRACHEAL TUBE (THE ENTIRE LENGTH IS INSERTED). THE POTENTIAL FOR POOR PT OUTCOME IS GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CATHETER SUCTION CATHETER BSY SUPERIOR HEALTHCARE GROUP, INC. 4298A

    Patients

    Seq Age Sex Outcome Treatment
    1 *