BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 18803509 · Received February 28, 2024

    Report

    Report Number
    3012307300-2024-01066
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 24, 2024
    Report Date
    April 10, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: ITEM NUMBER, LOT NUMBER, UDI NUMBER, EXPIRATION DATE, D5: OPERATOR OF DEVICE, G5: 510K NUMBER, AND H4: MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    TWO DEVICES WERE RECEIVED FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY INSPECTED AT 12¿ TO 16¿ AND NORMAL CONDITIONS OF ILLUMINATION. SAMPLE ONE HAS A CUT IN THE FLANGE AND A HOLE ON THE CUFF. SAMPLE TWO HAS A CUT IN THE FLANGE. THE REPORTED COMPLAINT IS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED AS NO ITEM/LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "FOUND BROKEN ON THE PERSON AND TWO MORE IN PATIENT'S ROOM; 2 TRACHS, PHALANGE #1". AFFECTED QUANTITY OF THREE REPORTED. THE CUSTOMER DOES NOT TRACK THEIR TRACHS BY LOT NUMBER. THEY ARE ISSUED OR DELIVERED TO INPATIENT NURSING. UNFORTUNATELY, THE BOX WOULD HAVE THE LOT NUMBER ON IT BUT ONCE USED THE BOX IS DISCARDED. "THE BIVONA TRACHS ARE RE-STERILIZED AT THE UC MEDICAL." IT IS UN-CLEAR IF THIS DEVICE HAD BEEN RE-PROCESSED. THE BROKEN FLANGE WAS FOUND PRIOR TO A TRACH CHANGE. IT WAS REPORTED THAT "NO HARM CAME TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895701 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male