BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11099191 · Received December 30, 2020

    Report

    Report Number
    3012307300-2020-12890
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 1, 2020
    Report Date
    March 2, 2021
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586022128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD CASSETTE WAS RETURNED FOR ANALYSIS. LEAK TESTING ON THE SAMPLE RECEIVED WAS PERFORMED USING A SYRINGE TO LOOK FOR UNUSUAL FUNCTIONS. NO LEAK WAS DETECTED. THE COMPLAINT WAS NOT CONFIRMED. PRODUCTION PERSONNEL TURN TUBE BACK AND FORTH FOR A MINIMUM OF TWO (2) SECONDS. REMOVE IMMEDIATELY AFTER TWO SECONDS WITH A MAXIMUM OF FIVE SECONDS IN THE SOLVENT ACCORDING TO PROCEDURE. PRODUCTION JOIN ALL COMPONENTS IMMEDIATELY AFTER SOLVENT APPLICATION. PRODUCTION PERFORMS 100 PERCENT VISUAL INSPECTION TO ASSURE THAT THE PARTS SHALL NOT BE DAMAGED INCLUDING SCRATCHES) OR DISTORTED WARPED. PRODUCTION PERFORMS 100 PERCENT LEAK TEST TO ASSURE ASSEMBLIES HAVE BEEN MANUFACTURED IN ACCORDANCE TO PROCEDURE AND THE TUBE AND BAG COMPONENTS DOES NOT PRESENT A LEAK OVERALL. PER PROCEDURE QUALITY SAMPLE 15 UNITS AT AN INTERVAL OF TWO HOURS PLUS OR MINUS 30 MINUTES, PRIOR TO PLACING PRODUCT IN BAG IN ORDER TO VERIFY PARTS ARE FREE OF DAMAGE, SCUFFS, PINCH MARKS, ETC.), CRACKS, CRAZING, CUTS, OR OTHER WORKMANSHIP DEFECTS THAT CAN AFFECT ASSEMBLY APPEARANCE AND FUNCTION.

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE IS UNKNOWN SINCE THE SPECIFIC LOT IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT THE PRODUCT LEAKED INTO THE HOUSING CASSETTE. THIS OCCURRED DURING FILLING, SO IT HAD NOT LEFT THE PHARMACY DEPARTMENT. CUSTOMER IS NOT SURE OF THE AFFECTED LOT, BUT THEY REPORT THAT IT IS ONE OF TWO LOT NUMBERS (3840915 OR 18X068).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558230 CADD INTRAVASCULAR ADMINISTRATION SET FRN ST PAUL 21-7002-24 10610586022128

    Patients

    Seq Age Sex Outcome Treatment
    1