BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    03201 EYE PADS

    MDR report key: 6309141 · Received February 7, 2017

    Report

    Report Number
    1018120-2017-00024
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    COVIDIEN
    Product Code
    HMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WERE REVIEWED THERE WERE NO ISSUES. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED ON TIME. THERE WERE NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT OR DESCRIBE CHANGES THAT OCCURRED. THE OEE SHEET FOR THE LINE ON THIS DAY SHOWS NO UNUSUAL DOWNTIME OR EVENT THAT COULD CAUSE THIS ISSUE. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND ALL MACHINE PARAMETERS WERE SET WITHIN VALIDATED SPECIFICATIONS. ALL IN PROCESS CHECKS WERE CONDUCTED AND FOUND NO ISSUES. PHOTOS WERE PROVIDED FOR SAMPLE ANALYSIS. THE PHOTOS INDICATED A SMALL TEAR IN THE CENTER OF EACH PAD WITHIN THE SEAL TOWARD THE BOTTOM OF THE PACKAGE. THE SAME TEARS ARE SEEN ON MULTIPLE PACKAGES. THE DEFECT IS CONFIRMED. THE CUSTOMER SENT BACK 7 BOXES OF SAMPLES THAT WERE UNOPENED AND UNUSED ON 10/20/2016. AFTER A 100% INSPECTION, NO PACKAGES WITH THE SMALL TEARS PICTURED IN THE PHOTOS TAKEN BY THE CUSTOMER WERE FOUND. ON THIS MACHINE, A CHAIN WITH METAL TABS CARRIES THE EYEPAD CUTOUT FROM THE COTTON TOWARD THE PAPER TO BE PACKAGED. AS IT APPROACHES THE AREA TO BE INSERTED BETWEEN THE PAPER, THE METAL TABS ROTATE ALONG A ROLLER AND MOVE OUT OF THE WAY TO NOT MAKE CONTACT WITH THE PAPER. THIS ISSUE COULD HAVE OCCURRED FROM A BENT TAB SUCH THAT IT MADE A SMALL HOLE EVERY SEVERAL TABS. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED FOR THIS ISSUE. IT MUST BE NOTED THAT IN-PROCESS CONTROLS ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING ACTIVITIES. IN ADDITION, AS A PREVENTIVE ACTION FOR MANUFACTURING SITE OPERATIONS, A MONTHLY COMPLAINTS REPORT IS SENT TO FOCUS FACTORY PERSONNEL, SUMMARIZING THE LATEST EVENTS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH AN EYE GAUZE PAD. THE CUSTOMER STATES THERE ARE HOLES/TEARS IN THE PEEL POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92392 03201 EYE PADS EYE GAUZE PAD HMP COVIDIEN 03201 15M171162

    Patients

    Seq Age Sex Outcome Treatment
    1