BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE SOL ADMIN SET

    MDR report key: 1973457 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00538
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    November 28, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN AN ACTUAL SAMPLE FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND BAXTER WAS NOT ABLE TO CONFIRM THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE BATCH REVIEW CAN NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A FOLLOW-UP WILL BE PERFORMED IF ANY ADDITIONAL INFORMATION CONCERNING THE REPORTED CONDITION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A SOLUTION ADMINISTRATION SET THAT WAS DIFFICULT TO DISCONNECT THE MALE LUER FROM THE CATHETER SET. THE ROTATING MALE LUER LOCK SEPARATED FROM THE MALE LUER WHEN UNTIGHTENING THE LUER FROM THE CATHETER. THIS REPORTED CONDITION OCCURRED WHILE THE SET WAS BEING USED ON A PATIENT. THERE WAS NO PATIENT INJURY INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CATHETER SET, UNKNOWN SOLUTION