BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE SOL ADMIN SET 3WAY

    MDR report key: 1913097 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05391
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 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). CORRECTION. SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT 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.

    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. 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 THAT SHOWED DIFFICULTIES DURING USE. ACCORDING TO THE REPORT, THE ADMINISTRATION DID NOT STOP WHEN THERE WAS NO FLUID LEFT IN THE SOLUTION BAG. IT WAS ALSO REPORTED THAT THIS IS A RECURRING ISSUE THAT HAS OCCURRED AN UNSPECIFIED NUMBER OF TIMES IN THE PAST. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION IS 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 3WAY STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 10F27V751

    Patients

    Seq Age Sex Outcome Treatment
    1