BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SUCTION VALVE (STERILE)

    MDR report key: 8594970 · Received May 9, 2019

    Report

    Report Number
    8594970
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 26, 2019
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A BRONCHOSCOPY WITH EBUS, THE SUCTION VALVE AND TUBING CAME OFF THE EBUS SCOPE AND SPLATTERED THE ROOM, CEILING AND 4 STAFF MEMBERS WITH BLOOD. STAFF DID NOT HAVE A BLOOD AND BODY FLUID EXPOSURE TO NON INTACT SKIN OR ORIFICES. PHYSICIAN FEELS THAT EITHER THE SUCTION VALVE IS NOT SECURED TIGHTLY OR THAT THE WEIGHT OF THE SUCTION TUBING IS PULLING IT OFF. PHYSICIAN STATES HE NORMALLY CHECKS THE SUCTION VALVE BEFORE STARTING THE PROCEDURE AND SECURES IT. HOWEVER, WITH THIS CASE HE DID NOT CHECK TO MAKE SURE THE SUCTION VALVE WAS TIGHT. MANUFACTURER RESPONSE FOR SUCTION VALVE, SINGLE USE SUCTION VALVE (PER SITE REPORTER): OLYMPUS MEDICAL CONTACTED AT (B)(4). PRODUCT RETURNED TO (B)(4) ON 5/1/2019 VIA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389407 SINGLE USE SUCTION VALVE (STERILE) BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ OLYMPUS SURGICAL TECHNOLOGIES AMERICA MAJ-209

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA