BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    MDR report key: 4182101 · Received October 14, 2014

    Report

    Report Number
    3003563511-2014-00069
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    RAYNOR INTRAOCULAR LENSES LIMITED
    Product Code
    MSS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST STEP IN THE INJECTOR LOADING SECTION OF THE IFU STATES "...FULLY RETRACT THE PLUNGER ENSURING THAT THE SOFT TIP DOES NOT PROTRUDE INTO THE LOADING BAY. DO NOT ADVANCE THE PLUNGER PRIOR TO LOADING THE LENS". THE INFORMATION RECEIVED FROM THE DISTRIBUTOR SUGGESTS THAT THE PLUNGER WAS DEPRESSED MORE THAN ONE PRIOR TO THE LENS BEING LOADED IN THE INJECTOR. THIS IS A DIRECT DEVIATION FROM THE INSTRUCTIONS PROVIDED BY RAYNER.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE FINNISH DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR (MODEL: R-INJ-04). THE EVENT DESCRIPTION PROVIDED SATES "...THE BLUE TIP OF THE PLUNGER DID NOT FIT THE NOZZLE OF THE INJECTOR, BUT WAS REPEATEDLY BENT TO THE LOADING BAY". FOR FURTHER INFORMATION PLEASE REFER TO RAYNER'S MDR 9611165-2014-00069.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648751 SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNOR INTRAOCULAR LENSES LIMITED R-INJ-04 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1