BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 9638737 · Received January 28, 2020

    Report

    Report Number
    3012307300-2020-00637
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    December 27, 2019
    Report Date
    March 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15019517190380
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TWO DEVICES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE CONNECTOR WAS SHAVED OFF- MISSING CHUNKS OF PLASTIC. VISUAL INSPECTION USING A MAGNIFIED LIGHTED LAMP REVEALED THAT THE INSIDE OF THE CONNECTOR HAD ABRASION MARKS. THE ABRASION MARKS WERE THE RESULT OF A DREMEL DEVICE BEING USED INSIDE THE CONNECTOR EITHER TO REMOVE EXCESSIVE ADHESIVE THAT HAD MIGRATED INSIDE THE CONNECTOR WHEN ATTACHING THE SHAFT OR TO REDUCE THE PORTION OF THE SHAFT THAT MAY HAVE EXTENDED PAST THE INSIDE OPENING OF THE CONNECTOR. THE ROUGH SURFACE OF THE INSIDE OF THE CONNECTOR WAS DEEMED NOT TO AFFECT FIT, FORM, OR FUNCTION OF THE DEVICE. THE REPORTED CUSTOMER COMPLAINT HAS NOT BEEN CONFIRMED, AS THIS PROCESS IS COMMON AND NECESSARY FOR DEVICES BUILT IN THE CUSTOM LAB.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME. THE PATIENT'S MOTHER WAS PREPARING A PLANNED TUBE CHANGE FOR THE INDWELLING DEVICE AND NOTICED THE "PLASTIC PIECE INSIDE THE 15MM ISO WAS SHAVING OFF AND MISSING SOME CHUNKS OF PLASTIC". THE SAME ISSUE WAS NOTICED ON THE REPLACEMENT TUBE AS IT WAS CHECKED PRIOR TO PLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102393 PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. ZU19BN45NGF065S DS030674 15019517190380

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR