BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 CATARACT PACK

    MDR report key: 23189698 · Received October 1, 2025

    Report

    Report Number
    1423395-2025-00154
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, MULTIPLE INSTANCES OF CLOGGED 27G NEEDLES WERE FOUND IN THE PACKS. THE CUSTOMER STATED THAT THE ISSUE WAS DISCOVERED WHEN THE "SURGEON ATTEMPTS TO INJECT MEDICATION THROUGH IT" AT THE END OF THE PROCEDURE. THE CUSTOMER SAID THAT ONCE A CLOGGED NEEDLE WAS DISCOVERED, IT WAS REPLACED WITH A NEW NEEDLE. ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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.

    Additional Manufacturer Narrative · 0

    UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, MULTIPLE INSTANCES OF CLOGGED 27G NEEDLES WERE FOUND IN THE PACKS. THE CUSTOMER STATED THAT THE ISSUE WAS DISCOVERED WHEN THE "SURGEON ATTEMPTS TO INJECT MEDICATION THROUGH IT" AT THE END OF THE PROCEDURE. THE CUSTOMER SAID THAT ONCE A CLOGGED NEEDLE WAS DISCOVERED, IT WAS REPLACED WITH A NEW NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015466 2.4 CATARACT PACK OJK MEDLINE INDUSTRIES, LP 25DMJ692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other