BEUDAMED
    FDA Adverse Event Summary report: N

    BINOVA FLEXTEND

    MDR report key: 2921425 · Received January 10, 2013

    Report

    Report Number
    2921425
    Date Received
    January 10, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SMITHS MEDICAL
    Product Code
    BTO
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    TRACHEOSTOMY TUBE BACKORDER FOR 3.0 UNCUFFED FLEXTEND 60PFSS30, SMITH MEDICAL NORTH AMERICA.======================MANUFACTURER RESPONSE FOR 3.0 UNCUFFED FLEXTEND, 3.0 UNCUFFED FLEXTEND (PER SITE REPORTER).======================"AS YOU MAY RECALL WE HAD ISSUES WITH THE SUCTION CATHETER PASSING ON SOME OF THE CUSTOMIZED CUFFED FLEXTENDS ESPECIALLY IN THE 3.0, 3.5 AND 4.0 SIZE. QUITE SOME TIME AGO WE ADDED A NEW INSPECTION CRITERIA TO PASS A CATHETER AT THE TIME OF QA INSPECTION BUT CONTINUE TO GET SOME COMPLAINTS IN THE FIELD DUE TO VARIATIONS IN CATHETERS AND THE TUBE TO ACTUALLY BEING IN THE PATIENT. WE OPENED A CORRECTIVE ACTION AND HAVE NOW CHANGED THE WAY THE TUBE IS EXTRUDED BUT ARE GOING THROUGH SOME CHALLENGES WITH THE NEW PROCESS. THIS WILL NOT BE A LONG-TERM ISSUE BUT WE WILL CONTINUE TO SEE SOME SHORTAGES IN THE COMPONENTS SUPPLIED TO THE CUSTOM LAB WHICH IN TURN CAUSES LATE ORDERS TO YOU. WE REALIZE THE IMPORTANCE AND ARE WORKING HARD TO RECTIFY THE SHORTAGES. IT IS VERY FRUSTRATING TO ALL AND HOPEFULLY WE WILL SEE IMPROVEMENT SOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16241 BINOVA FLEXTEND TUBE TRACHEOSTOMY BTO SMITHS MEDICAL 60PFSS30 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES