BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3132372 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13468
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED, ALONG WITH A COMPANION SAMPLE, FOR EVALUATION. A VISUAL EXAMINATION OF THE ACTUAL SAMPLE FOUND THAT THE LUER LOCK WAS MISSING, WHICH CONFIRMED THE REPORTED CONDITION. HOWEVER, THE COMPANION SAMPLE WAS FOUND WITH THE LUER LOCK IN PLACE. A PULL TEST WAS PERFORMED ON THE COMPANION SAMPLE AND NO DISCONNECTION OCCURRED DURING THE TESTING. THE CAUSE WAS DETERMINED TO BE AN OPERATOR ERROR DURING THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION: PER REVIEW OF THE BATCH RECORDS, AN ISSUE WITH THE LUER LOCK FOUND. HOWEVER, THE BATCH WAS REWORKED AND ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT PRIOR TO RELEASE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEHP FREE SOLUTION ADMINISTRATION SET, WITH INJECTION SITE, WAS MISSING THE BLUE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234823 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12I30V805

    Patients

    Seq Age Sex Outcome Treatment
    1