BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS - FLOW STOP

    MDR report key: 8497150 · Received April 9, 2019

    Report

    Report Number
    3012307300-2019-01502
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 8, 2019
    Report Date
    June 12, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586043239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PICTURE OF A CADD ADMINISTRATION SET WAS RECEIVED. IT CAN BE OBSERVED FROM THE PICTURE THAT THE FILTER SIDE HAS NO DROPS OR LEAKS. NO TESTING OR THOROUGH INSPECTION COULD BE PERFORMED BECAUSE NO SAMPLES WERE PROVIDED FOR EVALUATION. PER PREVIOUS COMPLAINT A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE REPORTED EVENT. NO DISCREPANCIES WERE FOUND, QUALITY PERSONNEL VERIFY THAT TESTS ARE PROPERLY PERFORMED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS CADD ADMINISTRATION SET EXHIBITED LEAKING. IT WAS REPORTED THAT THE LEAKING OCCURRED AT THE FILTER. THE ADMINISTRATION SET WAS DISCARDED AFTER THE EVENT. THE THERAPY INCLUDED FOLLOWING MEDICATION AND DEVICES: INFUSION BAG BAXTER 500 OR 1000 ML NACL 0.9% + THREE TYPES OF CYTOSTATICS, CYTO-AD-Z INLINE / 4 FROM CODAN, SWANLOCK AND PICC LINE (DOUBLE LUMEN). THE REPORTED EVENT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290389 CADD ADMINISTRATION SETS - FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 10610586043239

    Patients

    Seq Age Sex Outcome Treatment
    1