BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMEYES

    MDR report key: 12839109 · Received November 18, 2021

    Report

    Report Number
    3002808441-2021-00008
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BEAVER VISITEC INTERNATIONAL LIMITED
    Product Code
    PZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE THE SURGEON WENT TO INJECT THE ANTIBIOTIC AND NOTICED A BLACK FIBRE IN THE BARREL OF THE SYRINGE, OBVIOUSLY IT WAS IMMEDIATELY WITHDRAWN AND A NEW SYRINGE WAS USED. IT WAS REPORTED THAT IT LOOKS LIKE A STRAND OF RUBBER STILL ATTACHED TO THE RUBBER BUNG IS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738718 CUSTOMEYES CATARACT PROCEDURE PACK. PZG BEAVER VISITEC INTERNATIONAL LIMITED 588076 3366687

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown