BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE,25GX1.5",REG,BEVEL

    MDR report key: 20924838 · Received December 13, 2024

    Report

    Report Number
    1417592-2024-01033
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FMI
    UDI-DI
    40080196305576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, WHEN WE GO TO INJECT A PATIENT'S BODY PART THERE IS A LARGE AMOUNT OF RESISTANCE AND CANNOT PUSH THE STEROID OR LIDOCAINE THROUGH THE NEEDLE. YOU COULD NOT PUSH THE LAST 1CC OF MEDICATIONS INTO THE PATIENT. THE FACILITY STATED IT WOULD LEAD TO PULLING THE NEEDLE OUT AND HAVING TO REINJECT THE PATIENT. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. EXPIRATION DATES (UNABLE TO ENTER MORE THAN 1 EXPIRATION DATE IN SECTION D- EACH LOT HAS IT'S OWN EXPIRATION DATE): LOT 221203: 2027-11-03. LOT 231115: 2028-10-15. LOT 231227: 2028-11-27.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, WHEN WE GO TO INJECT A PATIENT'S BODY PART THERE IS A LARGE AMOUNT OF RESISTANCE AND CANNOT PUSH THE STEROID OR LIDOCAINE THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409738 NEEDLE,25GX1.5",REG,BEVEL FMI MEDLINE INDUSTRIES LP 221203, 231115, 231227 40080196305576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other