BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2941705 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02785
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS PERFORMED THAT REVEALED ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION AN INVERTED SEPTUM WAS IDENTIFIED; CONFIRMING THE CUSTOMER REPORTED CONDITION. THE ROOT CAUSE COULD NOT BE IDENTIFIED.(B)(4).

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE SENT BAXTER CORPORATE PRODUCT SURVEILLANCE AN EMAIL TO REPORT, ON BEHALF OF THE CUSTOMER, A BURETROL SET IN WHICH THE INTERLINK SEPTUM BECAME DISLODGED. ACCORDING TO THE REPORT, THE SEPTUM ON TOP OF THE BURETROL SET DISLODGED FROM THE INJECTION SITE AND INVERTED WHILE USING A BLUNT PLASTIC CANNULA TO GIVE A PATIENT IV MEDICATION. THE STAFF HAD TO START OVER WITH A NEW SET. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46557 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12I21094

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PLASTIC CANNULA