BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO GARD6201 COMPATIBLE BLOODSET

    MDR report key: 1860758 · Received October 7, 2010

    Report

    Report Number
    6000001-2010-03851
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 IS NOT AVAILABLE FOR EVALUATION. BATCH REVIEW WAS CONDUCTED WITH NO ABNORMALITY OBSERVED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LEAK NEAR THE FILTER AREA DURING PRIMING. THE LINE WAS DISPOSED OF AS IT WAS CONTAMINATED WITH BLOOD, AND A NEW LINE WAS PRIMED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO GARD6201 COMPATIBLE BLOODSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10E31V528M

    Patients

    Seq Age Sex Outcome Treatment
    1