BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRUNK INFANT NASAL TUBING

    MDR report key: 5821275 · Received July 26, 2016

    Report

    Report Number
    9611451-2016-00371
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Report Date
    June 30, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FLEXITRUNK INFANT NASAL TUBINGS ARE CURRENTLY EN-ROUTE TO FPH IN (B)(4) FOR INVESTIGATION, TO DETERMINE IF THEY HAD A MALFUNCTION WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO BC190-05 AND ONE BC192-05 FLEXITRUNK INFANT NASAL TUBING WERE RETURNED TO FPH IN NEW ZEALAND FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED. THE RETURNED DEVICES WERE ALSO PRESSURISED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. NOTE: DEVICE 1: BC190-05, 50MM LENGTH (LOT 160213, MANUFACTURED ON 13 FEBRUARY 2016). DEVICE 2: BC190-05, 50MM LENGTH (LOT 160331, MANUFACTURED ON 31 MARCH 2016). DEVICE 3: BC192-05, 100MM LENGTH (LOT UNKNOWN). RESULTS: VISUAL INSPECTION OF THE THREE RETURNED DEVICES REVEALED NO VISIBLE DAMAGE. WHEN THE RETURNED DEVICES WERE IMMERSED IN A WATER BATH, ALL EXHIBITED A LEAK BETWEEN THE TRILUMEN CONNECTOR AND EVAQUA TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160213 (DEVICE 1) AND LOT 160331 (DEVICE 2). A LOT CHECK COULD NOT BE PERFORMED FOR DEVICE 3 AS NO LOT INFORMATION WAS PROVIDED. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT HAD CAUSED THE REPORTED LEAKS. ALL FLEXITRUNK NASAL TUBINGS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT NASAL TUBING STATE: 'USE CAUTION WHEN POSITIONING THE INFANT INTERFACE. AVOID EXCESSIVE PULL FORCES, SHARP OBJECTS AND TUBING HOLDERS. DAMAGE TO THE TUBING MAY CAUSE LOSS OF PRESSURE AND REQUIRE IMMEDIATE REPLACEMENT.' A CAUTION INSERT IS INCLUDED IN THE PACKAGING TO REMIND THE USER TO TAKE EXTRA CARE WHEN HANDLING THE FLEXITRUNK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO BC190 AND ONE BC192 FLEXITRUNK INFANT NASAL TUBINGS WERE LEAKING AND FAILED THE LEAK TEST. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT TWO BC190-05 AND ONE BC192-05 FLEXITRUNK INFANT NASAL TUBING WERE LEAKING AND FAILED THE LEAK TEST. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476265 FLEXITRUNK INFANT NASAL TUBING BZO BZO FISHER & PAYKEL HEALTHCARE LTD BC190 & BC 192 2100025801

    Patients

    Seq Age Sex Outcome Treatment
    1