BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE ULTRA

    MDR report key: 8804846 · Received July 18, 2019

    Report

    Report Number
    3012307300-2019-03784
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    May 25, 2019
    Report Date
    September 19, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE (1) INNER CANNULA OF P/N 100/870/080 L/N UNKNOWN WAS RETURNED; THE RETURNED SAMPLE WERE RECEIVED IN USED CONDITION. DURING VISUAL INSPECTION A CRACKED INNER CANNULA WAS OBSERVED. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. THE MOST PROBABLE CAUSE IS: THE INNER CANNULA WAS CLEANED WITH ANOTHER SUBSTANCE , PERHAPS ALCOHOL THAT IS NOT THE ONE THAT MENTIONS THE CLEANING INSTRUCTIONS (INNER CANNULA CLEANNIG INSTRUCTIONS 10011781-001 ), WHICH TELLS YOU THAT IT SHOULD BE CLEANED WITH SALINE SOLUTION, THE MOST PROBABLY IS THE DEFECT OCCURRED AFTER OF MTIJ MANUFACTURING, BECAUSE DURING THE PACKING INNER CANNULA IN THE TRAY NOT USE ANY SUBSTANCE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER CANNULA WAS TORN 10 DAYS AFTER THE PRODUCT BEGAN TO BE USED. THE PORTEX TUBES BLUE LINE ULTRA TRACHEOSTOMY TUBE WAS BEING WASHED ONCE OR TWICE PER DAY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597225 BLUE LINE ULTRA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC

    Patients

    Seq Age Sex Outcome Treatment
    1