BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE SOL ADMIN SET WITH INJ SITE

    MDR report key: 2061102 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02928
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION/ADDITIONAL INFORMATION: THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE PREVIOUS MEDWATCH: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION ADMINISTRATION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, DURING THE CONNECTION OF THE SET, A LEAKAGE OF SOLUTION WAS OBSERVED AT THE LEVEL OF THE 3-WAY STOPCOCK. THE NURSE CHECKED THE SET AND NOTICED THAT THE LEAKAGE WAS DUE TO A DISCONNECTION OF THE TUBING AT THE LEVEL OF THE 3-WAY STOPCOCK. THE NURSE STOPPED THE ADMINISTRATION AND CHANGED THE SET. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEHP FREE SOL ADMIN SET WITH INJ SITE STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 10L01V878

    Patients

    Seq Age Sex Outcome Treatment
    1