BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, 3.0

    MDR report key: 5163298 · Received October 20, 2015

    Report

    Report Number
    3003898360-2015-00728
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 28, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE CUSTOMER RETURNED ONE OPENED POUCH OF PRODUCT 5-10406 FROM LOT # 73D1500523 FOR INVESTIGATION. THE RETURNED ET TUBE WAS VISUALLY EXAMINED WITH & WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THE ET TUBE APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE RETURNED ET TUBE WAS MEASURED FROM THE DISTAL TIP OF THE TUBE TOWARDS THE MACHINE END USING A CALIBRATED RULER ((B)(4)). THE MARKINGS WERE OBSERVED TO BE INCONSISTENT WITH THEIR PLACEMENT ALONG THE TUBE. WHEN PLACED AGAINST THE RULER, 8 CM LINES UP APPROXIMATELY 1 MM PAST THE '8' MARK ON THE TUBE, 10 CM LINES UP AT THE END OF THE '0' OF THE 10, 11 CM LINES UP AT THE END OF THE SECOND '1', 13 CM LINES UP APPROXIMATELY 1 MM PAST THE END OF THE '3', 14 CM LINES UP APPROXIMATELY 2 MM PAST THE END OF THE '4', AND 15 CM LINES UP APPROXIMATELY 2 MM PAST THE END OF THE '5'. THE DEVICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES "THE MARKINGS DEFINE THE DISTANCE FROM THE TIP OF THE TUBE, ACCURATE TO +/- 1 CM." OTHER REMARKS: A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE RETURNED PRODUCT WAS FOUND TO BE WITHIN SPECIFICATION AS THE MARKERS ARE LINED UP WITHIN 1 CM WHEN COMPARED TO A CALIBRATED RULER. THE REPORTED COMPLAINT OF MARKINGS ON THE ET TUBE ARE NOT CONSISTENT WITH MEASUREMENTS ON A RULER WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. ALL OF THE MARKINGS DID NOT FALL IN LINE WHEN COMPARED TO A CALIBRATED RULER. HOWEVER, PER THE IFU FOR THIS PRODUCT, 88445-12, "THE MARKINGS DEFINE THE DISTANCE FROM THE TIP OF THE TUBE, ACCURATE TO +/- 1 CM." NONE OF THE MARKINGS WERE OFF BY MORE THAN 2 MM. THEREFORE, BASED ON THE SAMPLE RECEIVED, THERE WERE NO DIMENSIONAL ISSUES FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE MARKINGS ON THE ENDOTRACHEAL TUBE ARE NOT CONSISTENT WITH THE MEASUREMENTS OF A RULER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693293 HUDSON ET TUBE, UNCUFFED, 3.0 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 73D1500523

    Patients

    Seq Age Sex Outcome Treatment
    1