BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK - MCLAREN BAY REGION

    MDR report key: 19782064 · Received July 19, 2024

    Report

    Report Number
    3015910259-2024-00021
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 11, 2024
    Report Date
    March 18, 2026
    Manufacturer
    MEDLINE 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 ON (B)(6) 2024 THE "DOCTOR PULLED BACK PLUNGER OF SYRINGE AND IT BROKE APART". THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REPORTED THEY UTILIZED ANOTHER SYRINGE AFTER THE INCIDENT OCCURRED. 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 ON (B)(6) 2024 THE "DOCTOR PULLED BACK PLUNGER OF SYRINGE AND IT BROKE APART".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549867 LHK - MCLAREN BAY REGION OEZ MEDLINE NAMIC 24BBG031 20197344009296

    Patients

    Seq Age Sex Outcome Treatment
    1