BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2990073 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05273
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE CONFIRMED THAT THE DISTAL LUER WAS CRACKED. THE ROOT CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE HAD A CRACK AND WAS "MISSING SOME PLASTIC" ON A LUER. THE DAMAGE WAS REPORTED TO BE ON THE PATIENT END OF THE TUBING. THIS MALFUNCTION WAS FOUND BEFORE USE AND THEREFORE THERE WAS NO PATIENT INVOLVEMENT. ALSO, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94018 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FRN BAXTER HEALTHCARE - IRVINE 12J062

    Patients

    Seq Age Sex Outcome Treatment
    1