BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 IN NON-DEHP MICROBORE EXTENSION SET

    MDR report key: 11729709 · Received April 26, 2021

    Report

    Report Number
    9616066-2021-50819
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403236257
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # (B)(4). INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THE END CONNECTOR BROKE OFF COMPLETELY, AND RETURNED THE USED SAMPLE, AND AN UNOPENED SAMPLE OF THE SAME LOT. THE UNUSED SAMPLE WAS OPENED AND TESTED FOR ANY DEFECTS, AND NONE WERE FOUND. THE SAMPLE WAS CLEARLY SEPARATED AT THE MALE LUER, AND THE COMPLAINT IS VERIFIED. THE USED SAMPLE WAS OBSERVED UNDER THE MICROSCOPE TO CHECK FOR DEFECTS. A DEVICE HISTORY RECORD REVIEW FOR MODEL ME2020 LOT NUMBER 19125802 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 14,403 UNITS IN 1 LOT NUMBER WAS BUILT ON 09DEC2019. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE IS INSUFFICIENT SOLVENT APPLIED DURING ASSEMBLY. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 60 IN NON-DEHP MICROBORE EXTENSION SET BROKE OFF FROM THE TUBING AFTER THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END CONNECTOR OF THE CAREFUSION 303, INC. MAXGUARD EXTENSION SET BROKE OFF COMPLETELY FROM THE TUBING AFTER THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618755 60 IN NON-DEHP MICROBORE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ME2020 19125802 50885403236257

    Patients

    Seq Age Sex Outcome Treatment
    1