BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    MDR report key: 5876744 · Received August 15, 2016

    Report

    Report Number
    2183502-2016-01724
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    June 22, 2016
    Report Date
    July 18, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K912469 & K083641. THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    MFR# CLARIFICATION: NEW REGISTRATION NUMBER (B)(4) HAS BEEN RECEIVED, HOWEVER, THIS INITIAL MDR WAS FILED UNDER THE PRIOR REGISTRATION NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ONE PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN A USED CONDITION AND WITHOUT ITS ORIGINAL PACKAGING. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE HAD MARKS ON THE EYELETS OF THE FLANGE. ONE WING OF THE NECK STRAP WAS ALSO DAMAGED. A REVIEW OF THE MANUFACTURING PROCESS FOR A SIMILAR PRODUCT WAS CONDUCTED; PERSONNEL HAD UP-TO-DATE CERTIFICATION AND NO DAMAGE WAS DETECTED ON THE ASSEMBLY UNITS. A REVIEW OF THE TESTING AND INSPECTION DOCUMENTS WAS CONDUCTED AND CONSIDERED ADEQUATE. BASED ON THE EVIDENCE, THE ROOT CAUSE WAS ATTRIBUTED TO DAMAGE THAT OCCURRED AFTER THE PRODUCT LEFT THE MANUFACTURING FACILITY. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SUPPLIER REPORTED ON BEHALF OF CUSTOMER THAT BIVONA CUFFLESS PEDIATRIC TRACHEOSTOMY TUBE WAS DAMAGED AT THE FLANGE WHILE CONDUCTING A TIE CHANGE AT THE PATIENT'S HOME AFTER HOURS OF USE. IT WAS REPORTED THAT THE TUBE WAS USED 2 TIMES AND THE DURATION OF TUBE USAGE WAS 2 WEEKS. THE TUBE WAS CLEANED WITH BOILING WATER AND HELD WITH MARPAC TRACHEOSTOMY TUBE HOLDER WITH TWILL TIES. THE TUBE WAS CHANGED EVERY 4 WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CAN'T BREATHE WITHOUT A TRACHEOSTOMY TUBE HOWEVER NOT VENTILATOR DEPENDENT. THIS OCCURRENCE DIDN'T CONTRIBUTE TO A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529062 BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1