BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1251643 · Received September 18, 2008

    Report

    Report Number
    9617604-2008-00108
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. TESTING REVEALED A TEAR OF 1.34 MM IN THE WALL OF THE PROD CUFF 30 MM FROM THE DISTAL TIP OF THE TUBE. A REVIEW OF OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR THE TWO POSSIBLE LOT NUMBERS IDENTIFIED. THOUGH THERE HAVE BEEN COMPLAINTS FOR CUFF DEFLATION IN USE, ON THIS PROD CODE DURING THE PAST FIVE YRS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF AN INFLATION CHECK CARRIED OUT ON 100% OF THIS PROD LINE PRIOR TO PACKAGING. ROOT CAUSE: IT IS STATED THAT THE UNIT WAS TESTED PRIOR TO USE AND ONLY BECAME DEFLATED AFTER 24 HRS 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 PRODS ARE DESIGNED TO BE AS ROBUST A FUNCTIONALLY POSSIBLE, PUNCTURE OF THE TUBE CUFF ON THE PT'S ANATOMY CAN BE EXPERIENCED. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1