BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2854852 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06315
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF A BURETROL ADMINISTRATION SET IN WHICH OPERATOR OBSERVED THE CONNECTOR WAS BROKEN WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LOWER CAP WAS BROKEN. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. 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

    A PHARMACIST OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A BURETROL ADMINISTRATION SET IN WHICH THE OPERATOR OBSERVED THAT THE CONNECTOR WAS BROKEN. 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 - CALI SE12CM4

    Patients

    Seq Age Sex Outcome Treatment
    1