BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET LL1000

    MDR report key: 1905194 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05155
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. 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 CONTAIN 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). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL INSPECTION REVEALED CRACKS ON THE FEMALE CONNECTOR OF THE SET. THIS DEFECT WAS ATTRIBUTED TO A RAW MATERIAL ISSUE AS THIS PART OF THE SET IS NOT MANUFACTURED AT THIS SITE, BUT PURCHASED FROM ANOTHER BAXTER MANUFACTURING SITE. BAXTER PERSONNEL IN THE PRODUCTION AREA WERE MADE AWARE OF THE REPORTED CONDITION. THIS PRODUCT HAS BEEN MANUFACTURED AT THIS PLANT SINCE 2006, AND A RAW MATERIAL DEFECT SUCH AS THIS HAS NEVER BEEN OBSERVED. A TREND REVIEW REVEALED NO SIMILAR REPORTS HAVE BEEN RECEIVED WITHIN THE PAST SIX MONTHS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EXTENSION SET THAT MALFUNCTIONED. THE PATIENT WAS RECEIVING AN INFUSION, WHEN, AT MIDNIGHT, HE HAD TO INTERRUPT THE TREATMENT BECAUSE THE SOLUTION CAME OUT FROM THE SITE OF CONNECTION OF THE EXTENSION SET WITH THE ADMINISTRATION SET. THE SOLUTION WENT ON THE FLOOR. NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET LL1000 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10A15V015

    Patients

    Seq Age Sex Outcome Treatment
    1