BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES POLAR

    MDR report key: 9742983 · Received February 23, 2020

    Report

    Report Number
    3012307300-2020-01421
    Event Type
    Malfunction
    Date Received
    February 23, 2020
    Report Date
    May 29, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    BTR
    UDI-DI
    15019315020353
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES POLAR TUBE. THE DEVICE WAS RETURNED IN ORIGINAL PACKAGE WITH P/N 100/133/070 AND L/N 3585172. UPON VISUAL INSPECTION FROM 12'-16" THE DEVICE OVERAL WAS IN GOOD CONDITION. TESTING WAS DONE BY INFLATING BALLOON UNDER WATER AND DISCOVERED TEAR AND LEAKING. THE QUALITY REVIEW WAS DONE (B)(6) 2020 P/N 100/133/065 L/N WITH REVIEWING MANUFACTURING PROCESS AND 32 SAMPES, WITH 100 % ACCURACY WITH NO DISCREPANCIES. FIVE SAMPLES WERE TAKEN AND DAMAGED TO REPLICATE EVENT. DIFFICULTY WITH TESTING, DO TO NO LIGHT WAS ON AND THE MECHANICAL ARM WAS NOT ACTIVATED, SO THE SAMPLES WERE REJECTED. PICTURES ATTACHED. THE COMPLAINT WAS NOT VERIFIED AS THE DEVICE PASSES 100% TESTING PRIOR TO RELEASE, ROOT CAUSE ISOLATED TO DEVICE BALLON BECOMING TORN ON SHARP EDGES AFTER RELEASED TO CONSUMER.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES POLAR WILL BE SUMMARIZED IN H-10

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES POLAR' WHEN INFLATING THE PROBE'S CUFF, IT BLEW.' NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206083 ENDOTRACHEAL TUBES POLAR TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD,INC TRACHEAL TUBE MAXILLO FACIAL N/NASAL IVORY S/SL 3585172 15019315020353

    Patients

    Seq Age Sex Outcome Treatment
    1