BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2232085 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22282
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE ACTUAL UNIT WAS RECEIVED FOR EVALUATION. THE UNIT WAS RECEIVED INSIDE A CAN LABELED CHEMOTHERAPY AND WAS WET WITH SOLUTION. THE UNIT WAS ATTACHED TO AN UNKNOWN SET. ONE PORT WAS BROKEN/INSERTED WITH AN UNKNOWN SPIKE. THE REPORTED CONDITION WAS CONFIRMED. THE POTENTIAL ROOT CAUSE FOR THIS INCIDENT IS RELATED TO THE USE OF A SET WITH A DIFFERENT SURFACE FINISH, WHEN COMPARED TO THE BAXTER SPECIFICATIONS. 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 ISSUE IS BEING INVESTIGATED THROUGH A CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CANADA OF AN INTRAVIA CONTAINER THAT HAD "THE INNER PART TUBING SEPARATED FROM THE BIGGER PORT." THE SECONDARY SET WAS REMOVED FROM THE LINE AND WRAPPED. THE CHEMOTHERAPY MEDICATION WAS COMPLETED SO THE PATIENT DID NOT MISS ANY OF HER DOSAGE, BUT IT RISKS FOR CHEMOTHERAPY SPILL AND SPLASH. THE PROBLEM OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR09I16065

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPEUTIC DRUG