BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO ADMON SOL PEEL POUCH

    MDR report key: 2052314 · Received April 12, 2011

    Report

    Report Number
    6000001-2011-02794
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 16, 2011
    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). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. DURING VISUAL INSPECTION THE ISSUE WAS CONFIRMED, BUT PUNCTURES AROUND THE NECK OF THE FLASHBALL WERE OBSERVED, AND NOT IN THE PLACE WHERE IT SHOULD BE DONE. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THE CONDITION WAS DETERMINED TO BE DUE TO INCORRECT USE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN ADMINISTRATION SOLUTION SET WITH LEAK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED FOR THIS EVENT. THE PATIENT WAS CONNECTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPO ADMON SOL PEEL POUCH SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SE11AI6

    Patients

    Seq Age Sex Outcome Treatment
    1