BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 15MM REUSABLE SWIVEL CONNECTOR

    MDR report key: 4230555 · Received October 10, 2014

    Report

    Report Number
    2183502-2014-00760
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE WAS IN USE WITH A PT FOR AN UNK AMOUNT OF TIME WHEN THE CONNECTOR WAS FOUND LEAKING. THE CLINICIAN INCREASED OXYGEN FLOW TO THE PT TO COMPENSATE FOR THE LEAKAGE. THERE WERE NO ADVERSE EFFECTS TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640862 PORTEX 15MM REUSABLE SWIVEL CONNECTOR CONNECTOR, AIRWAY (EXTENSION) BZA SMITHS MEDICAL INTERNATIONAL LTD NA 2500402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK