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: 8788575 · Received July 15, 2019

    Report

    Report Number
    3005997949-2019-00002
    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)_3005997949-2019-00001_BACK TABLE COVER CORRECTION, DATE SAMPLE RETURNED: 04JUN2019. TWO (2) SWATCHES WERE RETURNED OF THE BACK-TABLE COVER (BTC) MATERIAL - PAPER CLIPPED TO A PIECE OF PAPER WITH WHAT APPEARS TO BE THE PRODUCT INFORMATION. THE LOT NUMBER LISTED ON THE PAPER MATCHES THE LOT NUMBER REPORTED. NO FULL-SIZE SAMPLES WERE RECEIVED. THERE ARE HANDWRITTEN WORDS ON THE SAMPLE SWATCHES STATING, "NEW PACK" THEREFORE THE SAMPLE TYPE LISTED ABOVE IS CONSIDERED "REPRESENTATIVE". NO PRODUCT PACKAGING WAS RECEIVED. THE TWO (2) SWATCHES OF BTC MATERIAL WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SWATCHES OF BTC MATERIAL MEASURE AT LEAST 4" X 4" HOWEVER THE EDGES ARE NOT STRAIGHT, AND THE SHAPE OF THE SWATCHES IS IRREGULAR. BOTH SWATCHES ARRIVED WITH THE HANDWRITTEN WORDS "NEW PACK" WRITTEN IN PENCIL ALONG ONE EDGE. NO VISUAL LINT, PARTICULATES, STAINS, DISCOLORATION OR ANY ABRASION IS OBSERVED ON THE NONWOVEN SIDE. NO VISUAL DAMAGES ARE OBSERVED ON THE FILM SIDE. A REPRESENTATIVE AREA OF BOTH SWATCHES WAS VIEWED UNDER MAGNIFICATION ON BOTH SIDES. NO LINT, PARTICULATES, STAINS, DISCOLORATION OR ANY ABRASION IS OBSERVED ON THE NONWOVEN SIDE. NO VISUAL DAMAGES ARE OBSERVED ON THE FILM SIDE. BASED ON THE DEVICE HISTORY RECORD FOR LOT NUMBER AC9029081 REPRESENTATIVE SWATCHES AND PICTURES WERE PROVIDED FOR EVALUATION/ OBSERVATION AND 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 01AUG2019 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).

    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 SECOND OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00004 FOR THE FOURTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. REFER TO 3005997949-2019-00005 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00012. 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
    585112 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