BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11163328 · Received January 13, 2021

    Report

    Report Number
    3012307300-2021-00334
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 26, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517191738
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: ONE CADD ADMINISTRATION SET FROM PART NUMBER 21-7361-24 WITH LOT NUMBER 4034039 WAS RECEIVED IN DECONTAMINATED CONDITION INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. THE SAMPLE WAS RECEIVED WITH THE ASV LOOSE FROM THE TUBE, WHICH DOES NOT SHOW ENOUGH SOLVENT; THUS THE FAILURE MODE REPORTED IS CONFIRMED. THE SAMPLE RETURNED WAS TESTED USING THE HYDROSTATIC VESSEL. NO LEAKS WERE FOUND FLEEING FROM ANY JOINS. BASED ON THE ANALYSIS CONDUCTED WITH THE SAMPLE RECEIVED, THE FAILURE COULD NOT BE REPRODUCED, THEREFORE ACCORDING WITH THE PFMEA THE OCCURRENCE FOR THIS FAILURE CONDITION COULD BE CAUSED BY INCORRECT SOLVENT DISPENSE SET UP (INSUFFICIENT SOLVENT IN SOLVENT POT). THERE WAS NO FAULT FOUND WITH THE RETURNED ADMINISTRATION SET.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, LEAKING WAS NOTED AT THE DISTAL END OF THE TUBING WHERE THE LUER LOCK IS TO THE INJECTION CAP. IT WAS ALSO REPORTED THAT WHEN INTERLOCKED, THE PLASTIC HAS CRACKED. HIGH OCCLUSION ALARM WAS NOTED AND WAS NOT INFUSING PAST IN LINE FILTER. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60199 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7361-24 4034039 15019517191738

    Patients

    Seq Age Sex Outcome Treatment
    1