BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2212336 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18938
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 25, 2011
    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

    (B)(4). A CUSTOMER INITIALLY REPORTED A NONSTERILE SET. UPON FURTHER INVESTIGATION, THE CUSTOMER MODIFIED THEIR INITIAL REPORT AND STATED THAT THE SHIPPING CARTON OF THE SET DID NOT HAVE TAPE ON IT. THIS MODIFIED REPORT WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION AND/OR USE ERROR WERE TO RECUR. THEREFORE, NO EVALUATION WILL BE NECESSARY TO BE PERFORMED IN A MEDICAL DEVICE REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) A FLOGARD SET IN WHICH THE TAPE ON THE FLO-GARD INFUSION SET IS NOT PLACED CORRECTLY AND THE SET IS UNSTERILE. THIS CONDITION OCCURRED BEFORE-USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 11B11V467D

    Patients

    Seq Age Sex Outcome Treatment
    1