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: 8789017 · Received July 15, 2019

    Report

    Report Number
    3005997949-2019-00005
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 30, 2019
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651422164
    PMA / PMN Number
    D320421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION, SUBMISSION NAME: (B)(4)_3005997949-2019-00004_BACK TABLE COVER CORRECTION: THERE WERE ONLY 2 SAMPLES RETURNED FOR THIS COMPLAINT AND THE SAMPLE EVALUATION WAS INCLUDED IN THE FIRST 2 REPORTS. NO SAMPLE WAS RETURNED FOR THIS COMPLAINT. BASED ON THE DEVICE HISTORY RECORD FOR LOT NUMBER AC9029081 THE INCIDENT WAS NOT CONFIRMED. PER PROCESS ASSESSMENT AND REVIEW OF COMPLAINT TRENDS, A ROOT CAUSE WAS NOT IDENTIFIED FOR THE REPORTED INCIDENT; AND NO CORRECTIVE ACTIONS TAKEN. THE REPORTED PARTICLES ARE WHITE. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT THROUGH COMPLAINTS REVIEW BOARD (CRB) MONTHLY TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN IF INDICATED. ALL INFORMATION REASONABLY KNOWN AS OF 05AUG2019 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.

    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 INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 15JUL2019 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). 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

    DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON 15JUL2019. O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00002 FOR THE SECOND PATIENT-AVID MDR NUMBER 1047429-2019-00009. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00004 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. THE CUSTOMER REPORTED THE BACK-TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583505 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 30680651422164

    Patients

    Seq Age Sex Outcome Treatment
    1