BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2851382 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06143
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF 'A LUER ACTIVATED VALVE WHICH WAS FALLING OFF THE CHAMBER WHEN CONNECTING THE LINE AND IT LOOKS LIKE IT IS NOT SEALED' WAS CONFIRMED DURING SAMPLE EVALUATION. ONE CHAMBER WAS AVAILABLE AT THE PLANT FOR EVALUATION; HOWEVER, THE TUBE WAS NOT AVAILABLE. VISUAL INSPECTION REVEALED THAT THE CHAMBER HAD DISCONNECTED FROM THE SET. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BAXTER (B)(4) OF "A LUER ACTIVATED VALVE WHICH WAS FALLING OFF THE CHAMBER WHEN CONNECTING THE LINE AND IT LOOKS LIKE IT IS NOT SEALED." THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12D17V250

    Patients

    Seq Age Sex Outcome Treatment
    1