BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET

    MDR report key: 7640072 · Received June 26, 2018

    Report

    Report Number
    9616066-2018-00903
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    June 11, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A FLUID LEAK WAS NOT CONFIRMED. VISUAL INSPECTION OF THE SET DID NOT REVEAL ANY DISCERNIBLE SIGNS OF DAMAGE OR ABNORMALITIES WITH ANY OF THE COMPONENTS. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKING WITH ANY OF THE COMPONENTS. THE ROOT CAUSE OF THE REPORTED FAILURE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT FLUID LEAKED FROM BOTH THE TKO AND MEDLINE AT THE HUB WHILE CONNECTED TO A PATIENT. THE TKO, MEDLINE AND CAP WERE REPLACED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT HARM.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FLUID LEAKED FROM BOTH THE TKO AND MEDLINE AT THE HUB WHILE CONNECTED TO A PATIENT. THE TKO, MEDLINE AND CAP WERE REPLACED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479561 MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 10010570

    Patients

    Seq Age Sex Outcome Treatment
    1 MZ5307,MZ1000-07, THERAPY DATE UNK