BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC

    MDR report key: 14856943 · Received June 29, 2022

    Report

    Report Number
    3012307300-2022-12687
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    April 16, 2022
    Report Date
    April 27, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNABLE TO BE EVALUATED AS IT WAS NOT RETURNED. IF THE DEVICE IS RECEIVED IN THE FUTURE AN EVALUATION WILL BE PERFORMED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT IS TRACHY-VENTED DURING THE DAY AND NIGHT. MUM NOTICED THAT HER CHILD "DID NOT APPEAR RIGHT." MUM DESCRIBED HER CHILD LOOKING PUFFY EYED AND SECRETIONS WERE NOT CLEARING WHEN SHE WAS SUCTIONING HIM. THAT WAS WHEN SHE NOTICED A SPLIT AT THE END OF THE TRACHEOSTOMY TUBE (WHERE YOU CONNECT THE SWEDISH NOSE OR VENTILATOR TUBING). MUM HAD TO PERFORM AN EMERGENCY TRACHEOSTOMY TUBE CHANGE. THE SAME INCIDENT HAPPENED FOR THIS SECOND TUBE (WHICH WAS TO BE THE REPLACEMENT TUBE). IT WAS BELIEVE IT WAS A BRAND NEW TUBE FROM THE PACKAGING. FOR THE SECOND INCIDENT, MUM ALSO HAD TO PREFORM AN EMERGENCY TUBE CHANGE. TRACH 1 WAS INSERTED WHEN HE WAS AN INPATIENT AT (B)(6) HOSPITAL SO UNSURE HOW LONG THE TUBE HAD BEEN IN FOR. THE SECOND INCIDENT, THE TRACHEOSTOMY TUBE HAD BEEN IN FOR 11 DAYS AND WAS A BRAND NEW TUBE FROM AN UNOPENED PACKET. MUM BELIEVES THE FIRST INCIDENT INVOLVED A TRACHEOSTOMY TUBE THAT HAD BEEN BOUGHT BACK FROM STERILIZATION. PRODUCT DESCRIPTION: 3.5MM BIVONA PEDIATRIC CUFFLESS V NECK FLANGE TRACHEOSTOMY TUBE. ITEM AND LOT NUMBERS UNKNOWN. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 06-JUN-2022: NO HARM CAME TO THE PATIENT. PATIENT REQUIRED SUCTIONING AND AN EMERGENCY TUBE CHANGE. OUTCOME: ONGOING. TUBES HAVE BEEN SENT BACK TO THE SUPPLIER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 06-JUN-2022: IT WAS REPORTED THAT NO HARM CAME TO THE PATIENT. PATIENT REQUIRED SUCTIONING AND AN EMERGENCY TUBE CHANGE. OUTCOME: ONGOING.

    Description of Event or Problem · 0

    ADVERSE EVENT: MUM DESCRIBED HER CHILD LOOKING PUFFY EYED AND SECRETIONS WERE NOT CLEARING WHEN SHE WAS SUCTIONING HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089593 BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Male Required Intervention