BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR

    MDR report key: 7833029 · Received August 30, 2018

    Report

    Report Number
    9616066-2018-01476
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    July 7, 2018
    Report Date
    August 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230592
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (3) MZ1000-07, THERAPY DATE: (B)(6) 2018. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NIGHT RN NOTED PGE LEAKING AT THE "PIGTAIL". THE NURSE HAD TO REQUEST A NEW PGE FROM PHARMACY AND REPLACE THE TUBING THE PGE WAS INFUSING THROUGH. THE CUSTOMER LATER REPORTED THE "PIGTAIL" IS A MZ5306. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NIGHT RN NOTED PGE LEAKING AT THE "PIGTAIL". THE NURSE HAD TO REQUEST A NEW PGE FROM PHARMACY AND REPLACE THE TUBING THE PGE WAS INFUSING THROUGH. THE CUSTOMER LATER REPORTED THE "PIGTAIL" IS A MZ5306. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676137 MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ5306 10885403230592

    Patients

    Seq Age Sex Outcome Treatment
    1