BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRUNK INFANT NASAL TUBING

    MDR report key: 18619909 · Received January 31, 2024

    Report

    Report Number
    9611451-2024-00059
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 2, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) WE HAVE REQUESTED THE RETURN OF THE COMPLAINT BC191 FLEXITRUNK INFANT NASAL TUBING FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. SECTION D4 AND H4: DEVICE 1 & 2: LOT#: 2102325191 ; DATE OF MANUFACTURING: 29 AUG 2022 ; UDI: (B)(4) DEVICE 3 & 4: LOT#: 2102442007 ; DATE OF MANUFACTURING: 29 NOV 2022 ; UDI: (B)(4)2102442007(11)221129

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION D4 AND H4: DEVICE 1 & 2: LOT#: 2102325191 ; DATE OF MANUFACTURING: 29 AUG 2022 ; UDI: (B)(4). DEVICE 3 & 4: LOT#: 2102442007 ; DATE OF MANUFACTURING: 29 NOV 2022 ; UDI: (B)(4). METHOD: THE TWO COMPLAINT BC191 FLEXITRUNK INFANT NASAL TUBING WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE THEY WERE VISUALLY INSPECTED, AND PERFORMANCE TESTED. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE SUBJECT DEVICES, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION ON ONE OF THE COMPLAINT DEVICES REVEALED DAMAGE BETWEEN THE THIRD AND FOURTH AT THE CIRCUIT CONNECTOR SIDE. THE FILM WAS ALSO OBSERVED TO BE WRINKLED AND TORN, INDICATING THAT FORCE HAD BEEN APPLIED, CAUSING THE TUBE TO DEFORM AND THEN BREAK. PERFORMANCE TESTING OF THE SECOND TUBING REVEALED THAT THERE WAS NO LEAKING FROM THE TUBING. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE OBSERVED DAMAGE TO THE BC191 FLEXITRUNK INFANT NASAL TUBING. BASED ON OUR KNOWLEDGE OF THE PRODUCT THE TUBING WAS LIKELY SUBJECTED TO EXCESSIVE FORCE AS THE OBSERVED DAMAGE INDICATES THAT THE TUBING HAD BEEN PULLED TO AN UNINTENDED EXTENSION. ALL BC191 BUBBLE CPAP SYSTEMS ARE VISUALLY INSPECTED, AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE DAMAGE TO THE SUBJECT NASAL TUBING OCCURRED AFTER IT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE BC191 BUBBLE CPAP SYSTEM STATE: - "USE CAUTION WHEN POSITIONING OR DISCONNECTING TO 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 BC191 BUBBLE CPAP SYSTEM.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN BELGIUM REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF 4 BC191 FLEXITRUNK INFANT NASAL TUBES WERE FOUND TO BE DAMAGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN BELGIUM REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF (B)(4) (B)(6) FLEXITRUNK INFANT NASAL TUBES WERE FOUND TO BE DAMAGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374357 FLEXITRUNK INFANT NASAL TUBING BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED BC191 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown