BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET

    MDR report key: 5792541 · Received July 13, 2016

    Report

    Report Number
    9616066-2016-00942
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A CRACKED AND LEAKING EXTENSION SET LUER WAS CONFIRMED.MICROSCOPIC EXAMINATION CONFIRMED THE PRESENCE OF A CRACK SPANNING THE LENGTH OF THE LUER AND LUER TIP AND CONTINUING THROUGH THE EDGE OF THE LUER RIM.FUNCTIONAL TESTING CONFIRMED A SPRAYING LEAK AT THE CONNECTION SITE BETWEEN THE SYRINGE AND THE FEMALE LUER. THE ROOT CAUSE OF THE CRACK WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACK AT THE LUER OF AN EXTENSION SET WITHOUT ANY ADDITIONAL INFORMATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED; THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACK AND LEAK AT THE LUER OF AN EXTENSION SET MATED TO A SYRINGE DURING AN UNSPECIFIED INFUSION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION IS NOT AVAILABLE; THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446148 MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION C25006

    Patients

    Seq Age Sex Outcome Treatment
    1