BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ADJUSTABLE NASAL AIRWAY

    MDR report key: 4293235 · Received November 21, 2014

    Report

    Report Number
    8040412-2014-00270
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    May 8, 2014
    Report Date
    November 17, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER USER FACILITY, THE EXACT CATALOG NUMBER FOR THE DEVICE USED IN THIS EVENT IS UNKNOWN. THE PREFIX OF THE DEVICE IS REPORTED AS "(B)(4)". THE POTENTIAL SIZE OF THE DEVICE IS REPORTED AS: SIZE 26, 28 OR 30. THE LOT NUMBER IS UNKNOWN. THE USER FACILITY REPORTS THAT THERE WAS NO SIGNIFICANT PATIENT DAMAGE, BUT DIFFICULT TO JUDGE DUE TO THE FACT THAT THE PATIENT SHOWED SIGNS OF BRAIN DAMAGE PRIOR TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE PATIENT SATURATION DROPPED AND WHEN INTUBATING THE PATIENT THEY DISCOVERED THAT THE DEVICE ((B)(4) - PARTIAL MATERIAL NUMBER) HAD SLIPPED DOWN IN THE PATIENT'S THROAT. THE RUBBER RING THAT IS AROUND THE TUBE HAD SLIPPED OFF. THE USER FACILITY REPORTS THAT THE DEVICE MAY HAVE BEEN IN PLACE FOR A MAXIMUM OF 4 DAYS PRIOR TO THE EVENT. THE USER FACILITY ALSO REPORTS THAT A GREEN PLASTIC RING WAS ROUND IN THE BED. THE PATIENT WAS PLACED ON A RESPIRATOR FOR ONE DAY AND THEN EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758084 RUSCH ADJUSTABLE NASAL AIRWAY NASAL AIRWAY BTQ TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention