BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET SET

    MDR report key: 13232937 · Received January 11, 2022

    Report

    Report Number
    3012307300-2022-00543
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Report Date
    January 11, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    30610586023273
    PMA / PMN Number
    K873876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD EXTENSION SET, LINE LEAKED OVERNIGHT, WET SPOT IN THE BED. IT WAS REPORTED THE LEAKAGE WAS FROM THE CONNECTION, SEAM, UNDER THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738087 CADD EXTENSION SET SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 30610586023273

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown