BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2924089 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01521
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE DEFECTIVE SAMPLE WAS RETURNED AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBE HAD TWO SLITS IN TWO DIFFERENT PARTS OF THE TUBE. THE FIRST SLIT WAS AT 78CM FROM THE CHAMBER AND THE SECOND ONE AT 56CM FROM THE LUER. NO OTHER TEST WAS PERFORMED. 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. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. SHOULD RELEVANT 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 VENTED PACLITAXEL SET IN WHICH THE OPERATOR FOUND LEAKAGE FROM AN UNKNOWN LOCATION. THE REPORTED CONDITION OCCURRED DURING PRIMING. 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
    30118 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 12D13V136

    Patients

    Seq Age Sex Outcome Treatment
    1