BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRODISSECTION CANNULAE

    MDR report key: 17774018 · Received September 19, 2023

    Report

    Report Number
    0001920664-2023-70092
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    December 23, 2022
    Report Date
    August 24, 2023
    Manufacturer
    STERIMEDIX LIMITED
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED AS WE HAVE BEEN WORKING WITH OUR SUPPLIER AND OUR INTERNAL PRODUCTION TEAM TO IDENTIFY ANY PROCESSES THAT COULD HAVE CONTRIBUTED TO THIS NON-CONFORMANCE. WE WERE NOT ABLE TO LINK ANY OF THE ASSOCIATED PROCESSES OR MATERIALS USED TO THE NON-CONFORMANCE. IT IS HIGHLY UNLIKELY THAT THE PRODUCT CONTRIBUTED TO THE REPORTED ISSUE. IT IS MORE LIKELY THAT OTHER PRODUCTS OR DEVICES USED IN THE PROCEDURE EITHER CONTRIBUTED OR WERE SOLELY RESPONSIBLE FOR THE BLUE FIBRE PASSING THROUGH INTO THE PATIENT. THIS IS CONSIDERED AS AN ISOLATED INCIDENT, AND CONSIDER THIS INVESTIGATION CLOSED. SEE RELATED MEDWATCH REPORT NO. 0001920664-2023-70091.

    Additional Manufacturer Narrative · 0

    THERE ARE NO SAMPLES AVAILABLE TO BE RETURNED FOR FURTHER ANALYSIS. WE CONSIDER THIS ISSUE TO BE AN ISOLATED INCIDENT. NO SAMPLES FROM THE SAME BATCH WERE AVAILABLE FOR RETURN, AND THE PRODUCT WAS DISCARDED DURING THE PROCEDURE. 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.SEE RELATED MEDWATCH REPORT NO. 0001920664-2023-70091.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED. THIS INVESTIGATION IS ONGOING. SEE RELATED REPORT 0001920664-2023-70091.

    Description of Event or Problem · 0

    THE USER FACILITY IN THE NETHERLANDS REPORTED THAT DURING A CATARACT EXTRACTION PROCEDURE, A BLUE FIBER WAS FOUND IN THE PATIENT ''S EYE. THE FIBER WAS REMOVED WITH A PINCET. THE PROCEDURE WAS NOT PROLONGED. NO IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586100 HYDRODISSECTION CANNULAE OPHTHALMIC INFUSION/ASPIRATION CANNULA, SINGLE-USE HMX STERIMEDIX LIMITED M3907 442201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown