BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE

    MDR report key: 9176492 · Received October 10, 2019

    Report

    Report Number
    3012307300-2019-05554
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688518613
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE BIVONA SAMPLE WAS RECEIVED FOR EVALUATION IN USED CONDITION AND WITHOUT ITS ORIGINAL PACKAGING INSIDE A ZIPLOC BAG. VISUAL INSPECTION FOUND LOOSE CONTAMINATION ON THE UNIT. NEXT, THE SAMPLE WAS FILLED WITH 5CC OF AIR FOR FUNCTIONAL TESTING. WHEN INFLATING THE UNIT WITH AIR, THE CUFF INFLATED WITHOUT PROBLEMS. NO LEAKS WERE FOUND. UPON FURTHER LEAK TESTING THE DEVICE WAS INFLATED, AND IT WAS VISUALLY INSPECTED FOR 10 SECONDS, AND OBSERVED TO BE WELL INFLATED. SUBSEQUENTLY, THE UNIT WAS SUBMERGED UNDER WATER, NO LEAKAGE WAS OBSERVED. NEXT, THE INVESTIGATOR MASSAGED THE PRODUCT AND THE BALLOON WAS SQUEEZED WHERE THE AIRWAY LINE MOVED BACK AND FORTH, AND NO LEAKAGE WAS DETECTED. FURTHERMORE, NO LEAKS WERE FOUND WHEN THE DEVICE WAS FILLED WITH 5 CC OF WATER. ADDITIONALLY, THE AIRWAY LINE ASSEMBLY AND BALLOON ASSEMBLY WERE REVIEWED WITH NO DISCREPANCIES AND WERE AUDITED DURING THIRTY TWO (32) UNITS FINDING NO DEFLATED/INCORRECTLY INFLATED CUFFS. A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED AND WAS CONSIDERED ADEQUATE AND CORRECT. BASED ON THE EVIDENCE AND TESTING, THE COMPLAINT WAS NOT CONFIRMED. NO FAULT WAS FOUND WITH THE RETURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: LOT NUMBER WAS REPORTED AS UNKNOWN, BUT UPON DECEIVE RECEIPT, THE LOT NUMBER WAS NOTED AS 3802153. RELATED TO MFRS (SAME PATIENT WITH MULTIPLE OCCURRENCES): 3012307300-2019-05555, 3012307300-2019-05556.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME FOR SEVERAL DAYS. THE PATIENT'S MOTHER REPORTED THAT WATER FROM THE CUFF KEPT LEAKING BACK INTO THE PILOT BALLOON AND THEN THE TUBE CAME OUT ON ITS OWN. IT WAS STATED THIS HAPPENED THREE TIMES. THERE WERE NO ADVERSE PATIENT EFFECTS. THE REPORTER ALSO NOTED NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970759 PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 67PFS35 3802153 10351688518613

    Patients

    Seq Age Sex Outcome Treatment
    1