BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 897912 · Received August 16, 2007

    Report

    Report Number
    2936999-2007-00338
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Report Date
    August 16, 2007
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    BTO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THEY WILL RETURN THE PRODUCT TO NPB FOR EVALUATION.

    Description of Event or Problem · 1

    ON 07/18/2007, THE COMPANY RECEIVED A REPORT THAT THE INNER CANNULA WAS FOUND TO HAVE OBSTRUCTION IN THE LUMEN. THE CUSTOMER IS STATING THAT THEY WERE ROUTINELY SUCTIONING A PATIENT WHO HAS A 8DCT TRACHEOSTOMY TUBE. THEY WERE USING A 14 FRENCH SUCTION CATHETER. THEY ALSO DID A ROUTINE CHANGE OF THE 8DIC INNER CANNULA. THE CALLER REPORTED THAT THE PATIENT BECAME SHORT OF BREATH. THEY ATTEMPTED TO HYPERVENTILATE USING A BAG TO TRACH BUT FOUND IT DIFFICULT. THEY TRIED TO PASS THE SUCTION THROUGH THE LUMEN OF THE DIC BUT FOUND THAT THEY COULD NOT. THEY REMOVED THE DIC AND SUCTIONED THROUGH THE LUMEN OF THE OUTER CANNULA. THE DIC WAS REPLACED WITH A NEW ONE AND THERE WERE NO ADDITIONAL PROBLEMS. A SUCTION CATHETER PASSED THROUGH THIS DIC WITHOUT ISSUE. THE CALLER STATED THAT THE DIC IN QUESTION WAS EXAMINED AND A PIECE OF PLASTIC WAS SEEN AT THE POINT WHERE THE HUB JOINED THE CANNULA AND THAT THIS PLASTIC BLOCKED THE LUMEN OF THE TUBE. THE CALLER DOES NOT HAVE A LOT NUMBER FOR THE DIC IN QUESTION, BUT SHE HAS SAVED IT AND WILL RETURN IT TO TYCO FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT DISP. INNER CAN. 8 BX10 BTO JUAREZ HENEQUEN 8DIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR