BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAVY-DUTY BACK TABLE COVER, 60 IN. X 90 IN. / 152 CM X 229 CM

    MDR report key: 8930115 · Received August 26, 2019

    Report

    Report Number
    3005997949-2019-00015
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 2, 2019
    Report Date
    October 3, 2019
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651423079
    PMA / PMN Number
    D320421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT REPORTED FROM THE CUSTOMER IS AC9128122A AND WAS NOT RETURNED FOR EVALUATION. A SAMPLE EVALUATION WAS CONDUCTED ON THE REPRESENTATIVE SAMPLE RETURNED; HOWEVER THE ACTUAL PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION. A STERILE SAMPLE WAS RECEIVED FOR LOT NUMBER 1359022 AND THE SAMPLE WAS INSPECTED. A STANDARDIZED PROTOCOL OF INSPECTION WAS CONDUCTED; CAREFULLY UNWRAPPING THE BACK-TABLE COVER (BTC), INSPECTING THE BTC AND THEN INSPECTING EACH COMPONENT IN THE KIT. BECAUSE THE COMPLAINT IS ON THE BTC THERE WERE NO PARTICULATES OBSERVED ON THE BTC COMPONENT; THEREFORE, THIS COMPLAINT INCIDENT IS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 1359022 DETERMINED A ROOT CAUSE WAS NOT ESTABLISHED FOR THE REPORTED EVENT. ALSO, THE PRODUCT REPORTED HAS PARTICLES THAT ARE WHITE IN COLOR AND OUR BACK TABLE COVER IS BLUE. ALL INFORMATION REASONABLY KNOWN AS OF 24OCT2019 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

    MEDWATCH FORM MW (B)(4) WAS RECEIVED THAT STATES FIBERS WERE NOTICED IN THE PATIENT'S EYES AND THE PATIENT WAS MONITORED FOR INCREASED INCIDENCE OF INFLAMMATION. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09-AUG-2019 THAT STATES, "THIS IS BEING EVALUATED AT THE VA NATIONAL PATIENT SAFETY LEVEL. I CANNOT SHARE INFORMATION ON THESE CASES." NO ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 26AUG2019 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 · 1

    MEDWATCH FORM MW5087952 WAS RECEIVED ON 06AUG2019 THAT STATES FIBERS WERE NOTICED IN THE PATIENT'S EYES AND THE PATIENT WAS MONITORED FOR INCREASED INCIDENCE OF INFLAMMATION. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09-AUG-2019 THAT STATES, "THIS IS BEING EVALUATED AT THE VA NATIONAL PATIENT SAFETY LEVEL. I CANNOT SHARE INFORMATION ON THESE CASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726351 HEAVY-DUTY BACK TABLE COVER, 60 IN. X 90 IN. / 152 CM X 229 CM EQUIPMENT COVERS PUI O&M HALYARD, INC. 42307NS AC9128122 30680651423079

    Patients

    Seq Age Sex Outcome Treatment
    1