BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK OXYGEN MED CONC W/7FT U-CONN-IT TBG

    MDR report key: 2665733 · Received July 23, 2012

    Report

    Report Number
    8030673-2012-00160
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    June 26, 2012
    Report Date
    June 26, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVALUATION: THE CUSTOMER RETURNED SAMPLE WAS RECEIVED AND EVALUATED; NO PROBLEMS WERE IDENTIFIED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. IN ADDITION THE SUBASSEMBLYS WERE REVIEWED AND NO ISSUES WERE OBSERVED. OUR MANUFACTURING PROCESS WAS NOT REVIEWED BECAUSE PART# 001361-A WAS NOT BEING MANUFACTURED AT THE TIME OF REVIEW. THE MANUFACTURING PROCESS OF THE CONNECTOR WAS REVIEWED AND IT WAS OBSERVED THAT THE PIN WAS DAMAGED CAUSING THE CONNECTOR TO BE BLOCKED (AS SEEN IN THE ADDITIONAL REPORT FOR THIS ISSUE). NO ISSUES WERE FOUND WITH THE MATERIALS. CAREFUSION HAS OPENED A CORRECTIVE AND PREVENTATIVE ACTION TO DETERMINE THE ROOT CAUSE AND CORRECTIVE ACTIONS. THIS COMPLAINT WAS NOT CONFIRMED AS THE RETURN SAMPLE DID NOT HAVE ANY IDENTIFIED DEFICIENCIES.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CAREFUSION, OXYGEN BARBED INLET ADAPTER TIP OCCLUDED. NO FLOW ALLOWED. THIS REPORT IS FOR AN ADULT SIZE MEDIUM CONCENTRATION OXYGEN MASK WITH 7 FOOT U/CONNECT-IT TUBING. THE MASK WAS IN USE ON A PATIENT WHEN THE OCCLUSION WAS DISCOVERED. THE PATIENT'S OXYGEN SATURATIONS DROPPED WHICH ALERTED THE CLINICIAN TO THE ISSUE. THE MASK WAS EXCHANGED FOR AN ALTERNATE MASK AND OXYGEN WAS ADMINISTERED TO THE PATIENT. THE PATIENT RECOVERED AND THERE WAS NO LONG TERM HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK OXYGEN MED CONC W/7FT U-CONN-IT TBG MASK, OXYGEN BYG CAREFUSION 001361-A 0000437255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other