BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID TUBE WITH SOFT-SEAL CUFF AND INNER CANNULAE

    MDR report key: 8737066 · Received June 26, 2019

    Report

    Report Number
    3012307300-2019-02874
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 1, 2019
    Report Date
    September 8, 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: TWO (2) INNER CANNULA OF P/N 100/870/080 L/N UNKNOWN; THE RETURNED SAMPLES WERE RECEIVED IN USED CONDITION. DURING VISUAL INSPECTION, THE TWO-INNER CANNULAS WERE OBSERVED CRACKED. 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, WHICH TELLS YOU THAT IT SHOULD BE CLEANED WITH SALINE SOLUTION. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ULTRA SUCTIONAID TUBE WITH SOFT-SEAL CUFF AND INNER CANNULAE WAS CLEANED APPROXIMATELY ONCE OR TWICE PER DAY. AFTER TWO WEEKS OF USE, THE REPORTER FOUND A CRACK IN THE INNER CANNULA. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529880 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE WITH SOFT-SEAL CUFF AND INNER CANNULAE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1