BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT

    MDR report key: 6055343 · Received October 25, 2016

    Report

    Report Number
    3012307300-2016-00202
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    May 25, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. POSSIBLE 2 LOT NUMBERS: 2974360 / 3242938. LOT 2974360 - MANUFACTURE DATE: 28JUL2015; EXPIRATION DATE: 28JUL2020. LOT 3242938 - UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THREE DEVICES CONTRIBUTED TO THREE REPORTED EVENTS (ONE DEVICE PER EVENT). THE CUSTOMER RETURNED ONE DEVICE FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH REPORTED OCCURRENCE WAS ASSOCIATED WITH THE RETURNED DEVICE; THEREFORE, THE EVALUATION OF THE RETURNED DEVICE WILL BE USED FOR THE MEDWATCH. THE FOLLOWING MFR'S WERE SUBMITTED RELATED TO THE EVALUATION: 3012307300-2016-00202, 3012307300-2016-00228, AND 3012307300-2016-00229. ONE USED PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. THE RETURNED DEVICE WAS VISUALLY INSPECTED AT DISTANCE OF 12" TO 24" AND UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE OBSERVED DURING VISUAL INSPECTION. DURING FUNCTIONAL TESTING, A SYRINGE WAS USED TO INFLATE THE DEVICE CUFF WITH AIR AND THE DEVICE WAS SUBMERGED UNDER WATER. BUBBLES (INDICATING A LEAK) WERE OBSERVED ESCAPING FROM THE DEVICE CUFF. THE MANUFACTURING FACILITY PERFORMED A REVIEW OF THE MANUFACTURING PROCESS OF A SIMILAR PRODUCT. THE REVIEW SHOWED THAT ALL RELEVANT DOCUMENTS RELATED TO THE FIT CUFF, CUFF INFLATION, AND BLUE LINE TRACHEOSTOMY TUBE ASSEMBLY AND PACKAGING WERE ADEQUATE AND CORRECT. THE MANUFACTURING FACILITY ALSO PERFORMED AN IN-PROCESS VISUAL INSPECTION OF 32 PRODUCTS THAT WERE IN THE ASSEMBLY AREA: NO DEFLATED CUFFS WERE DETECTED. INVESTIGATION WAS UNABLE TO DEFINITELY DETERMINE THE ROOT CAUSE OF THE OBSERVED HOLE IN THE DEVICE CUFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FENESTRATED TRACHEAL TUBE CUFF LEAKED. THE CUSTOMER REPORTED THAT THE INCIDENT OCCURRED A TOTAL OF THREE TIMES. IT WAS REPORTED THAT THE CUFF WAS LEAKING AT THE SEAL. NO ADVERSE HEALTH OUTCOMES OCCURRED. SEE MFR: 3012307300-2016-00228 & 3012307300-2016-00229.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS IN PATIENT USE FOR APPROXIMATELY 7 TO 9 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704340 PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1