BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK W/ 040 ADAPTOR 650 ML

    MDR report key: 2021393 · Received February 8, 2011

    Report

    Report Number
    1417411-2011-00006
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    October 19, 2011
    Report Date
    January 18, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RECEIVED BY MFR FOR EVAL AT TIME OF THIS REPORT. THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE IS OXYGEN LEAKAGE AROUND THE ADAPTOR AT THE CONNECTION TO THE WATER BOTTLE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK W/ 040 ADAPTOR 650 ML AQUAPAK W/ ADAPTOR CAF TELEFLEX MEDICAL NA 87728

    Patients

    Seq Age Sex Outcome Treatment
    1