BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5933835 · Received September 7, 2016

    Report

    Report Number
    2183502-2016-01895
    Event Type
    Injury
    Date Received
    September 7, 2016
    Report Date
    August 10, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K913859 AND K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    THREE PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES WERE RETURNED FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH DEVICE WAS ASSOCIATED WITH THE REPORTED EVENT; THEREFORE, THE EVALUATION OF ALL RETURNED DEVICES WILL BE USED FOR THE MEDWATCH. VISUAL INSPECTION (UNAIDED AND MICROSCOPICALLY) FOUND SCUFF MARKS NOTED BY AN ABSENCE OF AN EXPECTED COATING AT BOTH SIDES OF THE PROXIMAL END OF THE CUFF. FUNCTIONAL TESTING INVOLVED A LEAK TEST AND SHOWED THAT THE CUFF LEAKED FROM THE SCUFFED AREA ON THE AIRWAY SIDE OF EACH DEVICE. BASED ON THE EVIDENCE, THE ROOT CAUSE OF THE MARKS ON THE CUFFS WAS UNABLE TO BE DETERMINED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT FROM THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE LEAKED OVER THE PAST MONTH. REPORTER NOTED THAT FAMILY MEMBER HEARD AIR BLOWING OUT OF PATIENT'S MOUTH AND FOUND WATER LEAKING AT END OF CUFF. PATIENT LEFT THE PREVIOUS HOSPITAL VISIT WITH 9-10CC OF STERILE WATER IN THE CUFF AND FAMILY MEMBER CLAIMS 15CC WAS USED TO SEAL THE CUFF INTO THE TRACHEA. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS CONDUCTED AFTER ABOUT 10 DAYS DUE TO TUBE LEAKING. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 2183502-2016-01893 AND 2183502-2016-01894.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584377 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention