BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN AND AEROSOL THERAPY

    MDR report key: 3971237 · Received July 9, 2014

    Report

    Report Number
    9680866-2014-00016
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 16, 2014
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A SERIOUS INJURY. AN INITIAL QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2014 AND THE FOLLOWING INFORMATION WAS PROVIDED ON (B)(4) 2014, "I'M SORRY BUT WE CANNOT PROVIDE DETAILED IDENTIFIERS SUCH AS END USER HEIGHT AND WEIGHT DUE TO OUR (B)(6) PRIVACY LEGISLATION. I ALSO DON'T KNOW WHETHER PRODUCT WAS REPLACED; ALL WE KNOW IS THAT THE CUSTOMER INSPECTED STOCK AT SEVERAL LOTS WHERE THE TAPE WAS NOT WELL APPLIED." ADDITIONAL INFORMATION WAS ALSO RECEIVED ON (B)(4) 2014 WHICH STATED, "AT THIS TIME I DON'T HAVE MORE INFORMATION, NEITHER REPORTS IN REGARDS TO THE "SEVERAL LOTS" THAT CUSTOMER MENTIONS. HOWEVER, CUSTOMER STATES THAT THEY "FOUND A COUPLE OF SAMPLES FROM SEVERAL LOTS WHERE THE TAPE WAS NOT WELL APPLIED." IT IS NOT AN ISSUE RELATED TO THE REPORTED DISCONNECTION OF TUBE FROM MASK CONNECTOR. I HAVE EXPLAINED CUSTOMER THAT THE TAPE HAS THE FUNCTION TO HOLD OR GLUE THE BAG TO MASK CONNECTOR. THIS TAPE COVERS THE SURFACE AROUND THE CONNECTION OF THE BAG AND MASK CONNECTOR. I WILL WAIT FOR THE SAMPLES TO EVALUATE AND DETERMINE IF IT IS SOMETHING WRONG WITH THE TAPE." THE COMPLAINT SAMPLE HAS BEEN REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING EVALUATED. THIS IS THE FIRST COMPLAINT OF THIS TYPE RECEIVED FOR THIS PRODUCT. NO PREVIOUS INVESTIGATION EXISTS FOR THIS ISSUE FOR THIS PRODUCT. BASED ON THIS REVIEW UNABLE TO DETERMINE IF PRODUCT MEETS SPECIFICATION. AN INVESTIGATION IS REQUIRED TO DETERMINE IF ANY FURTHER ACTIONS ARE REQUIRED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OXYGEN TUBING BECAME DISCONNECTED FROM THE BAG ATTACHMENT CREATING A LOSS OF OXYGEN DELIVERY TO THE PATIENT. THE PATIENT WAS FOUND WITH AN OXYGEN SATURATION OF 50% AND UNRESPONSIVE. BI-LEVEL POSITIVE AIRWAY PRESSURE WAS INITIATED AND PATIENT BECAME MORE RESPONSIVE AFTER 10-20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400594 OXYGEN AND AEROSOL THERAPY MASK, OXYGEN, NON-REBREATHING BYG UNOMEDICAL S.A. DE C.V. 3104-E 102787

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention