BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    MDR report key: 3072620 · Received April 19, 2013

    Report

    Report Number
    9611165-2013-00026
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    MSS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. THE DEVICE ANALYSIS CONFIRMED THE ORIGINAL COMPLAINT (FAULTY INJECTOR) AS REPORTED BY THE HEALTHCARE FACILITY; HOWEVER, WAS UNABLE TO ASCERTAIN A ROOT CAUSE. OUR REVIEW OF PRODUCTION RECORDS FOR THE R-INJ-04 INJECTOR BATCH B239 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL INJECTORS RELEASED FOR DISTRIBUTION FROM THIS BATCH MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE R-INJ-04 INJECTOR (DECEMBER 2011) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OR ANY TYPE, HAVE BEEN RECEIVED AGAINST THE R-INJ-04 INJECTOR BATCH B239. DESPITE VARIOUS ATTEMPTS MADE BY VIGILANCE PERSONNEL TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED EVENT, NO FURTHER DATA HAS BEEN FORTHCOMING FROM THE HEALTHCARE FACILITY. WITHOUT CLEAR EVENT DETAILS BEING PROVIDED A FAILURE MODE AND ROOT CAUSE ARE EXTREMELY DIFFICULT TO ASCERTAIN.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR (MODEL R-INJ-04). THE REPORT RECEIVED INDICATED THAT THE INJECTOR WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171100 SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LIMITED R-INJ-04 B239

    Patients

    Seq Age Sex Outcome Treatment
    1