BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SOFTECH CO2 SAMPLING CANNULA

    MDR report key: 2163504 · Received June 2, 2011

    Report

    Report Number
    3004365956-2011-00222
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 20, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT TUBING WAS MISTAKENLY CONNECTED TO THE PT IV TUBING. COMPLAINT STATES THE FOLLOWING: PT WAS TO RECEIVED ANTIBIOTICS IN THE MORNING. IV TUBING WAS CONNECTED PROPERLY. OXYGEN TUBING WITH CARBON DIOXIDE CONNECTOR HAD BEEN SENT UP TO THE FLOOR AFTER PT HAD A GI PROCEDURE. ATTENDING NURSE CONNECTED THE CARBON DIOXIDE CONNECTION ONTO ONE OF THE IV TUBING CONNECTIONS WHICH DIVERTED SOME OF THE MEDICATION INTO THE IV TUBING AND INTO THE PT'S NOSE. PT CURRENT CONDITION IS UNK. A MEDWATCH REPORT WAS RECEIVED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SOFTECH CO2 SAMPLING CANNULA SAMPLING CANNULA CAT TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR