BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE

    MDR report key: 16833857 · Received April 28, 2023

    Report

    Report Number
    3012307300-2023-04729
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 3, 2023
    Report Date
    February 21, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: D10. DEVICE AVAILABLE FOR EVALUATION, H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. D3, G1,2 EMAIL IS: [email protected]. TWO DEVICE SAMPLES WERE RECEIVED IN USED CONDITION WITHOUT THE ORIGINAL PACKAGING. PER VISUAL INSPECTION, THE SAMPLES WERE FOUND TO HAVE A DISCOLORED AREA AND SPLITTING. THE COMPLAINT WAS CONFIRMED. A ROOT CAUSE WAS NOT ESTABLISHED. BASED ON THE ANALYSIS CONDUCTED, THIS TYPE OF CONDITION CAN BE GENERATED DURING REPROCESSING FOR SUBSEQUENT USES DUE TO IMPROPER HANDLING OR USE OF LUBRICANTS OR CLEANING SOLUTIONS NOT RECOMMENDED, ROOT CAUSE CANNOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS SINCE THE FAILURE REPORTED COULD NOT BE REPRODUCED USING THE TOOLS FROM ASSEMBLY PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. NO CORRECTIVE ACTION WAS TAKEN SINCE THE INVESTIGATION DID NOT REVEAL THAT THE DEFECT WAS CAUSED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    D4: CATALOG NUMBER, LOT NUMBER, EXPIRATION DATE, UDI SECTION, AND H4: MANUFACTURE DATE ARE UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD A PEDIATRIC PATIENT WHO USES BIVONA NEONATAL FLEXTEND V FLANGE SIZE 4.0 TRACHEOSTOMY TUBES. THE PARENT CONTACTED CONCERNED THAT WHILE THE DEVICE WAS IS USE WITH THE PATIENT DURING A TRACH CHANGE, THEY HAD DISCOVERED A SPLIT, THAT IS NOT VISIBLE, IN THE AREA OF THE BACK OF THE TUBE. THE PLASTIC WAS ALSO NOTED TO BE DISCOLORED. THE 1ST TRACH (CC-0193352) REPORTS TO HAVE BEEN IN SITU WITH THE SAME PATIENT, 3 TIMES AND STERILIZED BETWEEN. THE 2ND TRACH (CC-0193358) REPORTS TO HAVE BEEN USED WITH THE SAME PATIENT 2 TIMES AND STERILIZED BETWEEN. THE CHILD HAD A PERIOD OF NEEDING TO BREATH VIA HIS STOMA. PARENT NEEDED TO KEEP HIM CALM AND GET HIM TO SIT IN A GOOD POSITION AND BREATHE CALMLY WHILST SHE FOUND A NEW TRACH. THEY WERE ABLE TO INSERT THE NEW TRACH WITHOUT ISSUE ONCE LOCATED. CHILD WAS COMPLIANT AND WAS ABLE TO TOLERATE THE BREATHING THROUGH HIS STOMA ALTHOUGH HE WASN'T COMFORTABLE DURING THIS TIME. NO OTHER MEDICAL INTERVENTION REQUIRED. UNFORTUNATELY, THE PARENT HAD DISPOSED OF THE ORIGINAL PACKAGING, SO THEY WERE UNABLE TO PROVIDE LOT AND ITEM NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476402 BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown