BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING CADD EXT SET

    MDR report key: 10046502 · Received May 11, 2020

    Report

    Report Number
    MW5094447
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Report Date
    May 5, 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

    SPONTANEOUS CALL FROM PT'S MOTHER REPORTS LEAKING OF TUBING - LOT 3926559. NO OTHER INFO KNOWN. DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO. DID WE (MFR) REPLACE THE DEVICE? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505416 TUBING CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3926559

    Patients

    Seq Age Sex Outcome Treatment
    1