BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K042172

    MDR report key: 15348824 · Received September 2, 2022

    Report

    Report Number
    3012307300-2022-17490
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    February 11, 2020
    Report Date
    September 2, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    30610586028391
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT COULD NOT BE CONFIRMED SINCE NO SAMPLES OR PICTURES WERE RECEIVED FOR EVALUATION. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA AT THE INFUSION SITE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676365 K042172 SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7230-24 30610586028391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown