BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACO (PHGSE)107

    MDR report key: 1957506 · Received January 11, 2011

    Report

    Report Number
    1423537-2011-00001
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENDOR A PLUS INTERNATIONAL INC RESPONDED: WE REVIEWED THE DEVICE HISTORY RECORD OF LOT F2263 WHICH WAS MANUFACTURED IN (B)(4) 2010. AS WITH ANY COTTON BASED TOWEL PRODUCTS USED FOR MEDICAL PURPOSES, IT IS VERY DIFFICULT TO TOTALLY ELIMINATE THE "LINT" IN THE FACTORY DUE TO THE NATURE OF THE COTTON YARN. THE POSSIBLE ROOT CAUSE MAY BE RELATED TO THE SUPPLIED COTTON FABRIC. AS CORRECTIVE AND PREVENTATIVE ACTIONS: REVIEW ALL SUPPLIERS OF MATERIAL FOR PAST QUALITY PERFORMANCE AND ADJUST PURCHASING PLANS TO INCLUDE THOSE WITH CONSISTENT QUALITY PERFORMANCE. THE MATERIAL SUPPLIER WAS INFORMED ABOUT THE INCIDENT AND ASKED TO PAY SPECIAL ATTENTION TO PREVENT THIN WEFT YARN WHEN THEY ARE WEAVING THE FABRIC. OUR FACTORY INSPECTORS ARE ALSO INSTRUCTED TO PAY SPECIAL ATTENTION DURING IN-COMING INSPECTION OF THE FABRICS TO BE SURE THE COTTON YARN MEETS REQUIREMENTS. THE QUALITY INSPECTORS HAVE BEEN INSTRUCTED TO PAY SPECIAL ATTENTION DURING THE ROUTINE IN-PROCESS AND FINAL INSPECTIONS FOR TOWEL LINT COMPLIANCE. ANY NON-CONFORMITY WOULD BE SORTED OUT FROM THE PRODUCTION. ALL OPERATORS ARE BEING RETRAINED TO ROUTINELY CLEAN THEIR WORKING STATION TO PREVENT THE LOOSE LINT STICKING BACK ONTO THE TOWEL. THE MANUFACTURING PROCESS HAS BEEN REVIEWED TO ENSURE THE FILTER HAS BEEN CLEANED AT LEAST TWICE PER SHIFT. CARDINAL HEALTH HAS CHECKED WITH THE CUSTOMER AND THEY DO NOT WANT TO CHANGE TOWELS AT THIS TIME.

    Description of Event or Problem · 1

    THE (B)(6) TOWELS (3) IN THE PACK ARE LEAVING FIBERS ON ALL THE CONTENTS OF THE PACK RESULTING IN THESE FIBERS ENTERING THE PATIENT'S EYE. THESE FIBERS HAVE TO BE REMOVED POST-OP AND IN THE DOCTOR'S OFFICE. ONE PATIENT REQUIRED ANTIBIOTICS. NO RESIDUAL EFFECTS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO (PHGSE)107 PHACO PACK LRO CARDINAL HEALTH SEY13PHGSF 613948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention