BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC KIT SYRINGE 2025-32-200662043

    MDR report key: 21858971 · Received April 17, 2025

    Report

    Report Number
    3015910259-2025-00032
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    OEZ
    UDI-DI
    10193489141306
    Product Problem
    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. THERE WAS NO FURTHER INFORMATION. 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 (B)(4) 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
    1763128 NAMIC KIT SYRINGE 2025-32-200662043 OEZ MEDLINE INDUSTRIES, LP - NAMIC 24LBN859 10193489141306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown