BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 10945765 · Received December 3, 2020

    Report

    Report Number
    MW5098205
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Report Date
    November 30, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT SPONTANEOUSLY STATES CASSETTES WERE LEAKING. THIS DID NOT OCCUR WHILE IN USE, NO INJURY TO PATIENT. CASSETTES WILL NOT BE RETURNED, AND REPLACEMENTS WILL BE SENT. BACKUPS WERE AVAILABLE FOR SUCCESSFUL LIKE SUSTAINING CONTINUES USE. LOT/BATCH NUMBER: 3983323, 4037751 - PATIENT NOT SURE WHICH NUMBER IS WHICH. OUTCOME OF EVENT IS RESOLVED. NO ADDITIONAL INFORMATION OR DATES AVAILABLE. REPORTED TO (B)(6) BY PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408048 CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3983323/4037751

    Patients

    Seq Age Sex Outcome Treatment
    1