BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOS

    MDR report key: 16797005 · Received April 24, 2023

    Report

    Report Number
    3012307300-2023-04453
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    February 10, 2022
    Report Date
    April 24, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KDZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# 617147. 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. D5: OPERATOR OF DEVICE IS UNKNOWN. E4: INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. D4: CATALOG NUMBER IS UNKNOWN. D4: UDI INFORMATION IS UNKNOWN. G5: PREMARKET (510K) NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT WAS LEAKING AND GIVING THE PATIENT HIGH DOSE OF PRESSOR. THIS WAS CAUSING PATIENT'S BLOOD PRESSURE DETERIORATION. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520652 MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOS INFUSOR, PRESSURE, FOR I.V. BAGS KDZ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other