BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 9969602 · Received April 16, 2020

    Report

    Report Number
    3012307300-2020-03205
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 19, 2020
    Report Date
    June 5, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE TRACHEOSTOMY TUBE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. SAMPLE UNDERWENT FUNCTIONAL TESTING AND LEAKAGE WAS DETECTED IN FILTER. A REVIEW OF THE PRODUCTION FLOOR WAS CONDUCTED, A SAMPLE OF 32 UNITS WERE TAKEN IN ORDER TO VERIFY THAT ALL JOINS ARE PROPERLY ADHERED; NO DISCREPANCIES WERE DETECTED. THE CUSTOMER RESPONSE WAS NOTED TO BE CONFIRMED AND THE PROBLEM SOURCE WAS DETERMINED TO BE MANUFACTURING.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: ONE CADD EXTENSION SET WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    SMJ#CFFF089. WHEN ADMINISTERING MEDICAL FLUID ("BLINCYTO" PROVIDED BY ASTELLAS PHARMA INC.) AT HOME, THE PATIENT NOTICED THE FLUID WAS LEAKING FROM THE AIR VENT PART OF THE FILTER. NO PATIENT INJURY.

    Description of Event or Problem · 0

    SMJ#CFFF089. WHEN ADMINISTERING MEDICAL FLUID ("BLINCYTO" PROVIDED BY ASTELLAS PHARMA INC.) AT HOME, THE PATIENT NOTICED THE FLUID WAS LEAKING FROM THE AIR VENT PART OF THE FILTER. NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ADMINISTERING MEDICAL FLUID ("BLINCYTO" PROVIDED BY (B)(6) AT HOME, THE PATIENT NOTICED THE FLUID WAS LEAKING FROM THE AIR VENT PART OF THE FILTER. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431153 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7106-24 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1