BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV SOL. ADMIN SET

    MDR report key: 1871814 · Received October 16, 2010

    Report

    Report Number
    6000001-2010-04091
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE ACTUAL SAMPLE AND ONE COMPANION SAMPLE OF (B)(4), WITH LOT NUMBER 10C10V866D FOR EVALUATION. THE REPORTED CONDITION OF A LEAKING SET WHEN INSERTED INTO THE BAG WAS UNABLE TO BE CONFIRMED. VISUAL INSPECTION DID NOT PRESENT ANY ANOMALIES. THE ACTUAL SAMPLE WAS LEAK TESTED AND NO LEAKS WERE FOUND. THE ACTUAL SAMPLE WAS ALSO ATTACHED TO A BAG, THE ROLLER CLAMP WAS CLOSED AND THE CHAMBER WAS PRIMED. THE RETURNED SAMPLE FUNCTIONED ACCORDING TO SPECIFICATION. A GRAVITY TEST WAS PERFORMED ON THE COMPANION SAMPLE AND THAT SAMPLE ALSO FUNCTIONED ACCORDING TO SPECIFICATION. A BATCH REVIEW WAS PERFORMED FOR THE REPORTED LOT. THE BATCH REVIEW REPORTS NO MANUFACTURING ABNORMALITIES AND THE LOT WAS DETERMINED TO BE WITHIN MANUFACTURING SPECIFICATIONS. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6) 2010 AN INCIDENT WHERE A SET LEAKED AFTER THE BAG WAS SPIKED. MEDICATION APPEARED TO BE RUNNING OUT OF THE TUBING WITH THIS FLOGARD IV SOLUTION ADMINISTRATION SET. THIS INCIDENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD IV SOL. ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10C10V866D

    Patients

    Seq Age Sex Outcome Treatment
    1