BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH FLEX DIC CUF 7.0MM

    MDR report key: 1169494 · Received September 18, 2008

    Report

    Report Number
    9610530-2008-00041
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 3, 2008
    Manufacturer
    SMITHS HEALTHCARE MFG SA DE C.V.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAME PT, WITH LOT 1212376, MANUFACTURED 10/2007. RESULTS EVAL - THE INVESTIGATION INTO THIS EVENT IS BASED ON HISTORY. NO SAMPLE WAS RETURNED DUE TO PT HAVING INFECTIOUS DISEASE, AND NO SAFE WAY TO SHIP SAMPLE BACK, OR TEST AFFECTED SAMPLES. REVIEW OF THE MFG RECORDS, FOR BOTH LOTS, REVEALED NO PROBLEMS DURING MANUFACTURE. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF AN INFLATION CHECK CARRIED OUT ON 100% OF THIS PRODUCT LINE PRIOR TO PACKAGING. PER REPORTER, THEY HAVE ONLY HAD ONE SIMILAR EVENT, WITH THIS CATALOG NUMBER, WITH A DIFFERENT PT. FIVE EVENTS WITH SAME PT, TWO LOTS. WITHOUT THE EVENT SAMPLES, THERE IS NO WAY TO DETERMINE POSITIVELY, HOWEVER, DUE TO HISTORY OF THIS TYPE OF REPORT, ROOT CAUSE LIKELY DUE TO PT ANATOMY. IT IS STATED THAT THE UNITS WERE TESTED PRIOR TO USE AND ONLY BECAME DEFLATED AFTER MORE THAN AN HOUR IN USE. AS SUCH, THIS INCIDENT IS UNLIKELY THE RESULT OF AN ASSEMBLY FAULT. WE HAVE DETERMINED THE ROOT CAUSE FOR THIS INCIDENT IS THAT THE CUFF BECAME SCRATCHED DURING INSERTION THROUGH THE STOMA AND SUBSEQUENTLY PUNCTURED FOLLOWING INSERTION. THOUGH THESE PRODUCTS ARE DESIGNED TO BE AS ROBUST AS FUNCTIONALLY POSSIBLE, PUNCTURE OF THE TUBE CUFF ON THE PT'S ANATOMY CAN BE EXPERIENCED.

    Description of Event or Problem · 1

    USER ALLEGES ONE UNIT HAS PINHOLES IN ANTERIOR UPPER SIDE OF THE CUFF. TRACHEOSTOMY TUBE HAD BEEN IN PLACE IN EXCESS OF ONE HOUR. FIVE EVENTS WITH SAME PT. UNIT WAS PRETESTED PER THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH FLEX DIC CUF 7.0MM 73 BTO - TRACHEOSTOMY TUBE, SINGLE-USE BTO SMITHS HEALTHCARE MFG SA DE C.V. 1079100

    Patients

    Seq Age Sex Outcome Treatment
    1