BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2792693 · Received October 16, 2012

    Report

    Report Number
    1416980-2012-02507
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER RECEIVED FOLLOW UP INFORMATION FROM CUSTOMER. THE CUSTOMER INFORMED THAT THE DRUG WAS ONLY ABLE TO INFUSE ONCE THE EXTENSION SET WAS TAKEN OUT AND CONNECTION WAS MADE DIRECTLY TO THE PATIENT CATHETER. UPON SPEAKING TO A BAXTER CLINICAL SPECIALIST, THE CUSTOMER WAS TOLD THEY SHOULD NOT BE USING THE STANDARD BORE TUBING, BUT THE MICROBORE TUBING. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE USE ERROR SINCE THE CUSTOMER USED THE INCORRECT PRODUCT FOR POWER INJECTION IN CT. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS ARE PRINTED ON EACH INDIVIDUAL PACKAGING ARE AVAILABLE TO THE USER AND ARE ACCURATE AND SUFFICIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A ONE LINK NEEDLE FREE IV CONNECTOR STANDARD BORE NON DEHP CATHETER SET HAD NO FLOW. THIS OCCURRED WITH AN UNKNOWN MEDICATION. THE REPORTED CONDITION OCCURRED DURING INFUSION, THEREFORE A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12F21017

    Patients

    Seq Age Sex Outcome Treatment
    1