BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORAY IV SET

    MDR report key: 1841671 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03463
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE WAS RECEIVED FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: THE CUSTOMER'S REPORTED CONDITION IS AGAINST A THIRD PARTY MANUFACTURER'S PRODUCT FOR WHICH BAXTER DOES NOT HAVE REPORTING RESPONSIBILITY.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LEAKAGE OF THE CONNECTING PART. THE REPORTED CONDITION OCCURRED DURING PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORAY IV SET SET, ADMINISTRATION, INTRAVASCULAR FPA 100612

    Patients

    Seq Age Sex Outcome Treatment
    1