BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV. SOLUTION ADMIN.SET

    MDR report key: 1863552 · Received October 11, 2010

    Report

    Report Number
    6000001-2010-03863
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. DURING VISUAL INSPECTION, THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. BATCH RECORDS WERE ALSO REVIEWED FOR THE REPORTED LOT AND WERE WITHIN SPECIFICATION.THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT A FLO-GARD IV. SOLUTION ADMIN.SET WAS DISCOVERED WITH CUTS PRESENT ON THE TUBING. THIS WAS ONLY VISIBLE AFTER TAKING THE PRODUCT OUT OF THE PACKAGING. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD IV. SOLUTION ADMIN.SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10E31V491D

    Patients

    Seq Age Sex Outcome Treatment
    1