BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE SOL ADMIN SET

    MDR report key: 1872671 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04136
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6), 2010 AN INCIDENT WHERE THE TUBING WAS LEAKING FROM THE CONNECTOR DUE TO A MISSING PLASTIC PART ON (B)(6), 2010 WITH THE DEHP FREE SOLUTION ADMINISTRATION SET. THIS INCIDENT OCCURRED DURING PRIMING / SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEHP FREE SOL ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10D30V255

    Patients

    Seq Age Sex Outcome Treatment
    1