BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRFIT

    MDR report key: 10589227 · Received September 25, 2020

    Report

    Report Number
    3012307300-2020-09833
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 7, 2020
    Report Date
    December 28, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    UDI-DI
    10610586044113
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PICTURES OF A CADD EXTENSION SET WERE RECEIVED FOR EVALUATION. THE PICTURE SHOWED ONE CASSETTE PRODUCT AND A CASSETTE EXTENSION SET WITH A BROKEN FEMALE LUER. ONE CADD CASSETTE PRODUCT FROM PART NUMBER 21-7605-24 AND UNKNOWN LOT NUMBER AND ONE CASSETTE EXTENSION TUBE WAS RECEIVED. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12? TO 24? AND NORMAL CONDITIONS OF ILLUMINATION. THE CASSETTE EXTENSION TUBE HAD A PIECE OF YELLOW CAP INSIDE OF THE FEMALE LUER . THE SAMPLE COULD NOT BE FUNCTIONALLY TESTED BECAUSE OF THIS CONDITION. A 21-7006-24 PRODUCT WAS USED TO PERFORM A YELLOW CAP ASSEMBLY MANUALLY; THE YELLOW CAP COULD NOT BREAK IN MANUAL ASSEMBLY EVEN WHEN APPLYING EXCESSIVE FORCE. THE ASSEMBLY BETWEEN THE FEMALE LUER AND YELLOW CAP WAS FIXED TO A PRESS TO MAKE IT POSSIBLE TO APPLY MORE FORCE IN ASSEMBLY. THE YELLOW CAP COULD BE BROKEN WHEN FIXED TO THE PRESS, HOWEVER THIS IS NOT NORMAL USE CONDITIONS FOR THE DISPOSITIVE. THE YELLOW CAP PRESENTED DEFORMATIONS AT THE MOMENT TO FIX TO THE PRESS. THE FAILURE MODE COULD NOT BE REPLICATED, THEREFORE THE ROOT CAUSE IS NOT ATTRIBUTABLE AT THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT COMPLAINED OF PAIN AND IT'S POSSIBLE THAT MEDICATION HAS NOT BEEN PASSING THROUGH THE CADD EXTENSION SET. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051591 NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC. 21-7605-24 10610586044113

    Patients

    Seq Age Sex Outcome Treatment
    1