BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK,-,HCA-HEALTHSTONE

    MDR report key: 21865226 · Received April 18, 2025

    Report

    Report Number
    3015910259-2025-00033
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 18, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    OEZ
    UDI-DI
    10193489141306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SYRINGE IS "LEAKING CONTRAST AT THE SYRINGE TIP". THE CUSTOMER DID NOT REPORT ANY PATIENT OR PROCEDURAL IMPACT AS A RESULT OF THE ISSUE. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE IS "LEAKING CONTRAST AT THE SYRINGE TIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763540 LHK,-,HCA-HEALTHSTONE OEZ MEDLINE INDUSTRIES, LP - NAMIC 24LBN852 10193489141306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other