BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2183185 · Received July 28, 2011

    Report

    Report Number
    6000001-2011-15379
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE ? SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE HENCE THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COMPLAINT REGARDING 1 UNIT OF INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105" IN WHICH THE SET LEAKED DURING INFUSION IN THE NUCLEAR MEDICINE DEPARTMENT. THE PROCESS STEP WAS DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE SAMPLE IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE ? SHERBROOKE ST11E286

    Patients

    Seq Age Sex Outcome Treatment
    1