BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLEX-OR

    MDR report key: 5353249 · Received July 27, 2005

    Report

    Report Number
    8020892-2005-00001
    Event Type
    Injury
    Date Received
    July 27, 2005
    Date of Event
    May 24, 2005
    Report Date
    July 27, 2005
    Manufacturer
    MILLIPORE CORP.
    Product Code
    JRL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT LABELING FOR MILLEX - OR STERILIZING FILTERS CLEARLY STATES 'DO NOT USE WITH SYRINGES SMALLER THAN 10CC'. UNFORTUNATELY, A 2CC SYRINGE WAS USED DURING THE COMPLAINT EVENT PROCEDURE. THE 2CC SYRINGE CAUSED THE NEED FOR OVER TIGHTENING AND FLUID PRESSURE BUILDUP. USE OF A SYRINGE 10CC (OR GREATER) WOULD ELIMINATE THE NEED FOR OVER TIGHTENING AND REDUCE THE FLUID PRESSURE WITHIN THE DEVICE ASSEMBLY. SINCE THE MILLEX - OR FILTER REFERENCE IN (B)(4) WAS 'MISUSED' ACCORDING TO PRODUCT LABEL STATEMENTS, THERE IS NO CORRECTIVE ACTION PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, THE MILLEX-OR STERILIZING FILTER (WITH DISPENSING TIP) DETACHED FROM THE SYRINGE AND WITH FORCE WAS PROJECTED INTO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLEX-OR STERILIZING FILTER JRL MILLIPORE CORP. MILLEX - .22U R4PN91767

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention