BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOELASTIC CANNULA

    MDR report key: 17851812 · Received October 2, 2023

    Report

    Report Number
    0001920664-2023-70100
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 6, 2023
    Manufacturer
    STERIMEDIX LIMITED
    Product Code
    HMX
    UDI-DI
    15056030400923
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS DISCARDED AND WILL NOT BE RETUNED FOR EVALUATION. THIS INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SAMPLES WERE RECEIVED . ON CLOSE INSPECTION UP TO 50 X MAGNIFICATION THERE WERE NO ANOMALIES IDENTIFIED, OR ANY EVIDENCE OF A WHITE POWDER OR LIQUID PRESENT IN THE LUMEN/HUB OR ON THE OUTSIDE OF THE PRODUCT. DI WATER WAS USED TO SOAK ONE OF THE SAMPLES FOR 30 MINUTES BEFORE INSPECTING UNDER 50 X MAGNIFICATION. USING MANUAL/VARIED PRESSURE DI WATER WAS RUN THROUGH THE LUMEN AND COLLECTED FOR CLOSE INSPECTION, WHICH RESULTED IN NO ANOMALIES BEING IDENTIFIED. THE REPORTED ISSUE IN THIS COMPLAINT COULD NOT BE QUALIFIED BASED ON THOROUGH EXAMINATION OF THE RETURNED SAMPLE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Additional Manufacturer Narrative · 0

    POTENTIAL ROOT CAUSE: WHEN CONSIDERING THE MATERIALS USED AND THE PROCESSES DURING MANUFACTURING (BOTH AT THE SUPPLIER AND STERIMEDIX), IT IS HIGHLY UNLIKELY THAT OUR PRODUCT CONTRIBUTED TO THE NON-CONFORMANCE REPORTED. IT IS MORE LIKELY THAT OTHER PRODUCTS OR DEVICES USED IN THE PROCEDURE EITHER CONTRIBUTED OR WERE SOLELY RESPONSIBLE FOR THE WHITE LIQUID PASSING THROUGH INTO THE PATIENT.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE UDI IS BEING PROVIDED.

    Description of Event or Problem · 0

    THE USER FACILITY IN JAPAN REPORTED THAT WHEN THE VISCOELASTIC MATERIAL WAS USED AND PUT INTO THE EYE, A WHITE LIQUID FIRST CAME OUT. THE TREATMENT WAS CATARACT SURGERY. NO SUTURES WERE USED AND THE INCISION SIZE WAS NOT INCREASED. THE PROCEDURE WAS NOT PROLONGED. THERE WAS NO IMPACT TO THE PATIENT AND NO ADDITIONAL ANESTHESIA REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836320 VISCOELASTIC CANNULA CANNULA, OPHTHALMIC HMX STERIMEDIX LIMITED M3925 451656 15056030400923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VISCOELASTIC MATERIAL SANTEN PHARMACEUTICAL.