BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK,-,CARLE,FOUNDATION HOSPITAL

    MDR report key: 19701904 · Received July 9, 2024

    Report

    Report Number
    3015910259-2024-00020
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    April 29, 2024
    Report Date
    March 12, 2026
    Manufacturer
    MEDLINE - NAMIC
    Product Code
    OEZ
    UDI-DI
    20193489189589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THREADS ON CONTROL SYRINGE WERE DAMAGED ON ONE AND THE SYRINGE BACKED ITSELF OFF OF THE MANIFOLD AFTER BEING FULLY THREADED ON". 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

    ACCORDING TO THE CUSTOMER, "THREADS ON CONTROL SYRINGE WERE DAMAGED ON ONE AND THE SYRINGE BACKED ITSELF OFF OF THE MANIFOLD AFTER BEING FULLY THREADED ON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536614 LHK,-,CARLE,FOUNDATION HOSPITAL OEZ MEDLINE - NAMIC 23KBW790 20193489189589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown