BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX CLEAR CUFF PRESSURE INFUSION

    MDR report key: 21020009 · Received December 26, 2024

    Report

    Report Number
    1526863-2024-00112
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 2, 2024
    Report Date
    February 19, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZD
    UDI-DI
    50351688507004
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DEVICE NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6. CODES: UPDATED. DEVICE EVALUATION: NO PRODUCT WAS RETURNED. PERFORMED VISUAL EVALUATION OF THE PICTURES PROVIDED AND COMPARED THE LOT NUMBER ON THE BOX LABEL AND LOT NUMBER PRINTED ON THE ASSEMBLIES. FINISHED ASSEMBLY ARE IDENTIFIED AS REQUIRED WITH LOT NUMBER TRACEABILITY, NO PROBLEM IDENTIFIED. COMPLETED ASSEMBLY OF THE FINISHED DEVICE AS A MX4810P1 OCCURRED IN ANOTHER ICU MEDICAL LOCATION IN THE EUROPEAN UNION WHERE THE PRODUCT WAS CE MARKED. THE FINISHED ASSEMBLY WAS PRODUCED FROM SUBASSEMBLIES(A4810) PROVIDED FROM THE DUBLIN, OHIO MANUFACTURING SITE, THESE SUBASSEMBLIES HAVE THEIR OWN LOT NUMBER IDENTIFICATION APPLIED DURING PRODUCTION. THE PRODUCT WAS PULLED FROM THE EU MARKET AS PART OF A CE RE-CLASSIFICATION PROJECT WITH ALL REMAINING INVENTORY FROM THE DISTRIBUTION CENTER SENT BACK TO THE DUBLIN, OHIO MANUFACTURING SITE TO BE REPACKAGED AS MX4810 PER APPROVED PROCEDURE AND ADDED INTO DUBLIN MANUFACTURING INVENTORY. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOT NUMBER INDICATED ON THE OUTSIDE OF THE PRODUCT BOX DOES NOT MATCH THE LOT NUMBER ON THE ITEMS INSIDE. THE EVENT OCCURRED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814249 MEDEX CLEAR CUFF PRESSURE INFUSION INFUSOR, PRESSURE, FOR I.V. BAGS KZD SMITHS MEDICAL ASD, INC. 6025032 50351688507004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown