BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE BLUE LINE ULTRA

    MDR report key: 9336969 · Received November 18, 2019

    Report

    Report Number
    3012307300-2019-06283
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    November 6, 2019
    Report Date
    March 10, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: THE FOLLOWING ITEMS WERE RETURNED FOR INVESTIGATION: 15 UNUSED B/L ULTRA SUCTIONAID W/INN CANN 8.5MM (PART NUMBER 100/870/085CZ). 1 USED DECONTAMINATED 8.5MM BLU SUCTIONAID SUB-ASSY (PART NUMBER 007/910/885). 2 UNUSED DECONTAMINATED 8.5MM BLU THIN WALL INNER CANN WITH STOP RING (PART NUMBER 005/073/685). 1 USED DECONTAMINATED 8.5MM BLU THIN WALL INNER CANNWITH STOP RING (PART NUMBER 005/073/685). UNDER VISUAL INSPECTION THE INVESTIGATOR NOTICED THAT 1 USED INNER CANNULA HAD A RESIDUES WHICH WERE OBSERVED BY THE CUSTOMER. FOR BETTER VIEW THE INVESTIGATOR SPLIT THE INNER CANNULA BY KNIFE ACROSS ITS LENGTH AND TOOK PHOTOS UNDER MAGNIFICATION. THE INVESTIGATOR WAS ABLE TO CONFIRM THAT THE INSIDE INNER CANNULA HAD SEVERAL STAINS OF DRIED MATERIAL. THE OTHER TWO DECONTAMINATED INNER CANNULAS WHICH WERE RETURNED DID NOT HAVE SUCH CONTAMINATION. THE INVESTIGATOR ALSO UNPACKED ALL 15 RETURNED UNIT PACKS AND VISUALLY INSPECTED THEIR INNER CANNULAS. THERE WERE NO DEFECT/STAINS FOUND ON THE UNITS. DUE TO THE FACT THAT THE PROBLEM WAS OBSERVED ONLY ON THE USED INNER CANNULA, AND BASED ALSO ON THE NATURE OF THE PRODUCT, IT IS HIGHLY IMPROBABLE THAT SUCH A DEFECT WAS CAUSED DURING THE MANUFACTURING PROCESS. THE REPORTED ISSUE WAS MOST LIKELY CAUSED BY DRIED MATERIAL FROM THE LUBRICATING GEL, MUCUS OR OTHER SECRETIONS. THESE SUBSTANCES SHOULD BE REMOVED DURING PERIODICAL CLEANING BY OPERATOR. THE PRODUCT PROBLEM WAS ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE FOR A BRONCHOSCOPY, " IT WAS DISCOVERED BY CHANCE THAT ON ONE SIDE OF THE INNER CANNULA A PART OF THE WALL HAS DETACHED US INTO THE LUMEN OF THE INNER CANNULA. POSSIBLY PARTS HAVE LOOSENED AND WERE SCATTERED IN THE LUNGS". NO MEDICAL PROCEDURE WAS REQUIRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130407 SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE BLUE LINE ULTRA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3778315

    Patients

    Seq Age Sex Outcome Treatment
    1