BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADDED HEAVY DUTY BACK TABLE COVER, 60IN X 90IN / 152 CM X 228 CM

    MDR report key: 17252934 · Received July 3, 2023

    Report

    Report Number
    3005997949-2023-00005
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 16, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651292699
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    RECEIVED A SECTION OF A FULL-SIZED SAMPLE. THE SECTION RECEIVED MEASURES APPROXIMATELY 7CM X 7.5CM. THE SAMPLE WAS EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE 7CM X 7.5CM SECTION OF SAMPLE CONSISTS OF ONE LAYER OF HEAVIER DARKER FILM, AND A LAMINATED LIGHT BLUE FILM WITH A NONWOVEN LAYER. THE NONWOVEN SIDE OF THE SAMPLE EXHIBITS A FOREIGN MATERIAL WHICH APPEARS EMBEDDED INTO THE NONWOVEN FIBERS OF THE SAMPLE. THE FOREIGN MATERIAL MEASURES APPROXIMATELY 1CM LONG AND AT THE WIDEST POINT MEASURES 8MM. THE SAMPLE WAS TURNED OVER FOR INSPECTION. THE FOREIGN MATERIAL IS NOT OBSERVED ON THE FILM SIDE. THE FOREIGN MATERIAL WAS VIEWED UNDER MAGNIFICATION. THE FOREIGN MATERIAL HAS THE APPEARANCE OF THE BODY OF A WINGED INSECT WHICH IS ENTANGLED OR ENTWINED WITH THE NONWOVEN FIBERS AND THEREFORE EMBEDDED IN THE NONWOVEN LAYER. THE LIGHT BLUE FILM WAS PEELED AWAY AND SEPARATED FROM THE NONWOVEN LAYER. THE APPARENT WINGED INSECT REMAINED ON THE NONWOVEN LAYER, CONFIRMING IT IS EMBEDDED INTO THE FIBERS OF THE NONWOVEN LAYER. BASED ON INCIDENT DESCRIPTION AND SAMPLE EVALUATION RESULTS, NO ROOT CAUSE WAS ESTABLISHED, BOTH LEXINGTON AND NOGALES HAVE CONTROLS IN PLACE TO MONITOR THE INSECT PRESENCE AT THEIR RESPECTIVE FACILITIES. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    A BUG WAS FOUND ON THE BACK TABLE COVER IN A STERILE PACK, AND WAS REMOVED FROM THE OPERATING ROOM. THERE WAS A DELAY IN SURGERY FOR 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253203 PADDED HEAVY DUTY BACK TABLE COVER, 60IN X 90IN / 152 CM X 228 CM SURGICAL ACCESSORIES PUI O&M HALYARD, INC. 29269 AC23008103 30680651292699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other