BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FREE VALVE

    MDR report key: 8362825 · Received February 22, 2019

    Report

    Report Number
    9616066-2019-00405
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    November 13, 2018
    Report Date
    January 28, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: FILE IS NO LONGER REPORTABLE, IT IS DETERMINED DEFECT WAS ON A NON-BD PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A GRAVITY INFUSION OF NORMAL SALINE WITH 2 UNITS OF HEPARIN/ML INTO THE CVP ON RIGHT JUGULAR CENTRAL LINE ON A NEONATE, THE BACK OF THE FILTER LEAKED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. CONCOMITANT MEDICAL PRODUCT: (3)CAPS; CENTRAL LINE, THERAPY DATE (B)(6) 2018.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GRAVITY INFUSION OF NORMAL SALINE WITH 2 UNITS OF HEPARIN/ML INTO THE CVP ON RIGHT JUGULAR CENTRAL LINE ON A NEONATE, THE BACK OF THE FILTER LEAKED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155664 NEEDLE FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2000E 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA B BRAUN STOPCOCK,NON-BD FILTER, TD 11/13/18.| B BRAUN STOPCOCK,NON-BD FILTER, TD : (B)(6) 2018