BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR, CASSETTE, 100ML, FS

    MDR report key: 7848675 · Received September 5, 2018

    Report

    Report Number
    3012307300-2018-03855
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    July 27, 2018
    Report Date
    November 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD EXTENSION SET WAS RETURNED FOR ANALYSIS IN USED CONDITION INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL SEALED PACKAGING. THE SAMPLE CONSIST OF ONE PRODUCT FROM EITHER L/N 3757311, 3757310, 3757312 OR 3761287. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. DELAMINATION WAS FOUND IN BOTH JOINS OF THE FILTER WITH THE TUBE. LEAK TESTING ON THE SAMPLE RECEIVED WAS PERFORMED USING HYDROSTAT VESSEL TO LOOK FOR UNUSUAL FUNCTIONS AND LEAKING WAS OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER IN THE SAMPLE. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 21-7106-24 L/N 3891180 WAS CONDUCTED BY A QUALITY ENGINEER ON 15-OCT-2019, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE "LEAKAGE AT THE FILTER OF THE TUBING" ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CASSETTE RESERVOIR LEAKED MEDICATION AS A RESULT OF A HOLE IN THE PRODUCT. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686327 RESERVOIR, CASSETTE, 100ML, FS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1