BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEA SUCTION SET

    MDR report key: 4232409 · Received September 18, 2014

    Report

    Report Number
    3007966929-2014-00095
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A QUALITY INVESTIGATION REVEALED THE PRODUCT WAS USED WRONGLY. NO ACTIONS ARE REQUIRED FROM MANUFACTURING SITE. ACCORDING TO THE PRODUCT SPECIALIST, THE NURSE WAS NOT USING THE PRODUCT ACCORDING TO MANUFACTURER INSTRUCTIONS. FURTHER TRAINING HAS BEEN RECOMMENDED. BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: ACTUAL DATE OF THE EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED DURING SUCTIONING OF THE PATIENT, THE NURSE EXPERIENCED THE SECRETIONS STAYED "IN THE TOP OF THE GLASS JUST UNDER THE LID WITH GREAT RISK OF SOAKING IT BACK INTO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578045 TRACHEA SUCTION SET TRACHEOBRONCHIAL SUCTION CATHETER BSY UNOMEDICAL LTD. 24001181 490794

    Patients

    Seq Age Sex Outcome Treatment
    1