BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2111987 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06994
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPA
    PMA / PMN Number
    K925058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE CAUSE WAS DETERMINED TO BE INCORRECT ASSEMBLY. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE CORRECTIVE AND PREVENTIVE ACTION IS BEING INVESTIGATED THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A BASIC SOLUTION SET FOR EPIDURAL ADMINISTRATION IN WHICH THE ROLLER CLAMP WAS UPSIDE DOWN. THE CONDITION WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 6 OF 12 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CLEVELAND GR293209

    Patients

    Seq Age Sex Outcome Treatment
    1