BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV SOLUTION ADMIN SET

    MDR report key: 1863885 · Received October 11, 2010

    Report

    Report Number
    6000001-2010-03940
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED TO BAXTER (B)(4) AND IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE SAMPLE IS EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. THROUGH VISUAL INSPECTION THE REPORTED CONDITION WAS CONFIRMED. THE SPIKE WAS BROKEN IN MORE THAN ONE PLACE AND WAS STUCK IN THE BAG PORT. IT WAS DETERMINED THAT THE SPIKE BROKE WHEN IT WAS INTRODUCED INTO THE BAG WHILE APPLYING LATERAL FORCES. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. A TREND REVIEW WAS PERFORMED AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6) 2010 AN INCIDENT WHERE THE TIP ON THE SET BROKE OFF 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 SOLUTION ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10F24V814D

    Patients

    Seq Age Sex Outcome Treatment
    1