BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN

    MDR report key: 8747882 · Received July 1, 2019

    Report

    Report Number
    3005997949-2019-00006
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    August 30, 2019
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    PMA / PMN Number
    D320421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION: HOWEVER, SAMPLE PHOTOS WERE PROVIDED FOR OBSERVATION AND THE INCIDENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NUMBER AC9029081 OF THE MANUFACTURED UNIT. THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. THE LOT MET THE PROCESS SPECIFICATIONS. NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. NO ROOT CAUSE WAS ESTABLISHED FOR THE REPORTED EVENT AND THE INCIDENT WAS NOT CONFIRMED. ALSO, THE PARTICLES REPORTED ARE WHITE IN COLOR AND OUR BACK TABLE COVER (BTC) IS BLUE. ALL INFORMATION REASONABLY KNOWN AS OF 30AUG2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRODUCT IS LEAVING LOOSE FIBERS IN THE PATIENT'S EYES AND ON THE STERILE FIELD. ADDITIONAL INFORMATION WAS RECEIVED THAT STATES ON (B)(6) 2019 TWO ADDITIONAL PATIENTS WERE FOR LOOSE FIBERS IN THE PATIENT'S EYES. THE ISSUE OF LINTING WAS FIRST DISCOVERED AFTER COMPLETION OF THE CATARACT PROCEDURE, WHEN THE PATIENTS RETURNED THE NEXT DAY FOR A SCHEDULED FOLLOW UP APPOINTMENT. LINT WAS DISCOVERED IN THE EYE AND THE PHYSICIAN PERFORMED A 2ND IRRIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT SAMPLE WAS NOT AVAILABLE OR RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 01JUL2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRODUCT IS LEAVING LOOSE FIBERS IN THE PATIENT'S EYES AND ON THE STERILE FIELD. ADDITIONAL INFORMATION WAS RECEIVED THAT STATES ON 06JUN2019 TWO ADDITIONAL PATIENTS WERE FOR LOOSE FIBERS IN THE PATIENT'S EYES. THE ISSUE OF LINTING WAS FIRST DISCOVERED AFTER COMPLETION OF THE CATARACT PROCEDURE, WHEN THE PATIENTS RETURNED THE NEXT DAY FOR A SCHEDULED FOLLOW UP APPOINTMENT. LINT WAS DISCOVERED IN THE EYE AND THE PHYSICIAN PERFORMED A 2ND IRRIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543933 HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN EQUIPMENT COVERS PUI O&M HALYARD, INC. 42216NS AC9029081

    Patients

    Seq Age Sex Outcome Treatment
    1