BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE SOL ADMIN SET WITH INJ SITE & 3WAY

    MDR report key: 1940895 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06312
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION ADMINISTRATION SET WITH 3-WAY STOPCOCK IN WHICH A NO FLOW OCCURRED. ACCORDING TO THE REPORT, THE FLOW REGULATOR WAS IN A FREE FLOW POSITION BUT THE SOLUTION DID NOT FLOW AND IT WAS IMPOSSIBLE TO PURGE. THE CONDITION OCCURRED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT. 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 & 3WAY STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 10I21V760

    Patients

    Seq Age Sex Outcome Treatment
    1