BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE TRI-PORT EXTENSION SET

    MDR report key: 7134819 · Received December 20, 2017

    Report

    Report Number
    9616066-2017-01654
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 5, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE LUER LOCK BREAKING WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT THE MALE LUER COLLAR CRACKED AND SEPARATED FROM THE SET. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT COULD NOT BE DETERMINED. THE CAUSE OF THE CRACK IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONT'D FROM MEDICAL DEVICES: 10ML ZR FLUSH SYRINGE, LOT 3131289, EXP 2019-08-01, 0.9%NACL, THERAPY DATE (B)(6) 2017. 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 THE PATIENT'S TUBING WAS BEING CHANGED AND THE LEUR-LOCK END OF THE IV TUBING BROKE (SEPARATED FROM THE ACTUAL TUBING), PREVENTING THE TUBING TO BE CONNECTED TO A SMARTSITE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913650 SMALLBORE TRI-PORT EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 20038E

    Patients

    Seq Age Sex Outcome Treatment
    1