BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV. SOLUTION ADMIN.SET

    MDR report key: 2001874 · Received February 25, 2011

    Report

    Report Number
    6000001-2011-01353
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    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). A SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO (B)(4) BAXTER OF A FLO-GARD SET IN WHICH THERE WAS A MALE LUER LOCK AT THE END OF THE TUBING MISSING. THIS REPORTED CONDITION OCCURRED DURING SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    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 10H31V488D

    Patients

    Seq Age Sex Outcome Treatment
    1