BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS

    MDR report key: 9940914 · Received April 8, 2020

    Report

    Report Number
    3012307300-2020-02795
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    January 1, 1901
    Report Date
    December 21, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FPA
    UDI-DI
    10610586027475
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: TWO CADD ADMINISTRATION SETS FROM P/N 21-7383-24 L/N 3780549 WERE RECEIVED FOR EVALUATION. ONE SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING, AND ONE SAMPLE WAS RECEIVED IN NEW CONDITION WITH ITS ORIGINAL CLOSED PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. THE SAMPLE RECEIVED WAS VISUALLY INSPECTED AND NO ABNORMALITIES WERE DETECTED. LEAK TESTING ON THE SAMPLE RECEIVED WAS PERFORMED USING HYDROSTAT VESSEL TO LOOK FOR UNUSUAL FUNCTIONS. A LEAK WAS OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. THE MOST PROBABLE CAUSE OF THE ISSUE IS THAT THE FILTER BECAME DAMAGE AFTER THE PRODUCT LEFT MANUFACTURING FACILITIES.

    Additional Manufacturer Narrative · 1

    THE AWARE DATE COULD BE POTENTIALLY (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET LEAKED AT THE FILTER. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397812 CADD ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC 21-7383-24 3780549 10610586027475

    Patients

    Seq Age Sex Outcome Treatment
    1