BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ADJ FLANGE NON LATEX NASA

    MDR report key: 2607434 · Received May 29, 2012

    Report

    Report Number
    8040412-2012-00084
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: "THE PHYSIOTHERAPIST HAD INTRODUCED THE NASOPHARYNGEAL TUBE, THE TIP HAD BEEN "STOPPED" AT THE PT'S OROPHARYNX. THEN, WHEN HE INTRODUCED AN ASPIRATION CATHETER THROUGH THE NASOPHARYNGEAL TUBE, THE TIP AND THE REST OF THE TUBE DISSOCIATED THEMSELVES, THE TIP REMAINED AROUND THE ASPIRATION CATHETER, AND THE REST OF THE TUBE WENT INTO THE PT'S PHARYNX. FORTUNATELY, THE TUBE COULD BE REMOVED BY ASPIRATION USING THE ASPIRATION CATHETER". FURTHER INFO: THE PT IS FINE. THIS INCIDENT HAPPENED DURING AN OPERATION IN WHICH THE PHYSIOTHERAPIST WANTED TO VACUUM FROM THE NOSE THE MUCUS WHICH BOTHERED THE PT. "BEFORE USE, THE PACKAGING WAS SEALED WELL: THAT'S WHY THE PHYSIOTHERAPIST DIDN'T CHECK ITS INTEGRITY. THE MEDICAL TEAM USED A LUBRICANT ON THE CANNULA". NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ADJ FLANGE NON LATEX NASA NASOPHARYNGEAL TUBE BTQ TELEFLEX MEDICAL 11L18

    Patients

    Seq Age Sex Outcome Treatment
    1