BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 11975913 · Received June 10, 2021

    Report

    Report Number
    3012307300-2021-05855
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 13, 2021
    Report Date
    March 7, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688518682
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    : H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. SAMPLES RECEIVED: THREE (3) SAMPLES WERE RECEIVED FROM P/N 67PFSS35 WITH L/N 4083925 AND 4100900 WITHOUT THEIR ORIGINAL PACKAGING INSIDE A ZIPLOC BAG, IN USED CONDITIONS AND WITH THEIR CERTIFICATE OF SAFE HANDLING. VISUAL INSPECTION: VISUAL INSPECTION WAS PERFORMED AT 12? UNDER NORMAL LIGHTING TO RECEIVED UNITS, IN ORDER TO DETECT ANY DAMAGE ON THE CUFF, AIRLINE OR PILOT BALLOON. RESULTS: NO DAMAGED COULD BE DETECTED. FUNCTIONAL TEST: SAMPLES WERE FILLED WITH 5CC OF AIR ACCORDING TO MP BIVONA TT-TJ130 REV. 102 ? (WI-MFG/INSPECT INSTRUCTIONS) IN ORDER TO SEE IF THERE WAS ANY FUNCTIONAL PROBLEM. RESULTS: WHEN WE INFLATED THE SAMPLE 1 WITH AIR, THE PILOT BALLOON INFLATED BUT ALL AIR WAS STUCK IT. ACCORDING TO THE IFU (10018853-001 REV.100 - IFU - PEDI/NEO TTS (PNT)) WE MANIPULATED THE PILOT BALLOON AND THE CUFF INFLATED BUT ONLY ONE SIDE, WE MANIPULATED THE CUFF AND THE WHOLE CUFF INFLATED. AFTER THE WHOLE CUFF INFLATED, WE DEFLATED AND INFLATED 4 TIMES, ALL THE TIMES THE CUFF INFLATED COMPLETELY. WE INFLATED THE UNITS, AND WE VISUALLY INSPECTED THEM FOR 10 SECONDS, WE DID NOT OBSERVE ANY LEAKAGE. THEN WE SUBMERGED THE UNITS UNDER WATER, WE DID NOT OBSERVE ANY LEAKAGE. WE WERE FOLLOWING MASSAGING THE CUFFS, WE SQUEEZED THEM, AND WE MOVED THE AIRWAY LINES BACK AND FORTH. WE DID NOT DETECTED LEAKS DURING THE TEST. THE COMPLAINT IS NOT CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. NO CORRECTIVE ACTIONS WERE TAKEN SINCE THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE'S BALLOON WAS NOT INFLATING. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870197 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 67PFSS35 4100900 10351688518682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown