BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK - MCLAREN BAY REGION

    MDR report key: 19811411 · Received July 23, 2024

    Report

    Report Number
    3015910259-2024-00022
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    May 21, 2024
    Report Date
    March 9, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    OEZ
    UDI-DI
    20197344009296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SYRINGE WOULDN'T STAY CONNECTED TO THE MANIFOLD. 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.

    Additional Manufacturer Narrative · 0

    UPDATE TO D3: MANUFACTURER NAME, CITY AND STATE. UPDATE TO E1: NAME AND ADDRESS. UPDATE TO H6: INVESTIGATION FINDINGS (C).

    Description of Event or Problem · 0

    SYRINGE NOT STAYING CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281184 LHK - MCLAREN BAY REGION OEZ MEDLINE INDUSTRIES, LP - NAMIC 24BBG031 20197344009296

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other