BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT NASAL CANNULA OXYGEN THERAPY

    MDR report key: 3003109 · Received March 13, 2013

    Report

    Report Number
    9611451-2013-00186
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BC2745-20 CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: UPON REQUESTING FURTHER INFORMATION THE HOSPITAL REPORTED THAT THE LEFT SIDE CANNULA TUBE WAS DETACHED FROM THE NASAL INTERFACE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 120428. CONCLUSION: WITHOUT THE RETURN OF THE COMPLIANT DEVICE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE HOSPITAL. HOWEVER IT IS POSSIBLE THAT THE TUBE DID NOT PROPERLY BOND TO THE NASAL INTERFACE OR THE BONDING AGENT WAS NOT SUFFICIENTLY APPLIED TO THE TUBING. THE BC2745-20 IS A SUPPLIED PRODUCT AND THE SUPPLIER HAS BEEN INFORMED OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE BC 2745-20 CANNULA WAS DISCONNECTED FROM THE CANNULA PART. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE BC 2745-20 CANNULA WAS DISCONNECTED FROM THE CANNULA PART. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105884 INFANT NASAL CANNULA OXYGEN THERAPY CAT CAT FISHER & PAYKEL HEALTHCARE LTD BC2745-20 120428

    Patients

    Seq Age Sex Outcome Treatment
    1