BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD U-BAR PACK VII

    MDR report key: 24401963 · Received February 20, 2026

    Report

    Report Number
    3005997949-2026-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Report Date
    March 13, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LRO
    UDI-DI
    30680651777691
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS EXAMINED UNDER AMBIENT LIGHT CONDITIONS. A DARK FOREIGN MATERIAL, MEASURING APPROXIMATELY 1.5 CM, WAS OBSERVED AFFIXED TO THE ADHESIVE. UNDER MAGNIFICATION, THE FOREIGN MATERIAL RESEMBLED A CRUSHED WINGED INSECT, WITH REDDISH STAINS AROUND AND NEAR IT. THE PORTION THAT REMAINED ON THE POLY BAG ALSO SHOWED FRAGMENTS THAT COULD BE DESCRIBED AS A WING AND SEVERAL APPENDAGES. OBSERVATIONS INDICATE THE APPARENT INSECT IS ON THE OUTSIDE OF THE ADHESIVE AND NOT BETWEEN THE ADHESIVE AND THE DRAPE MATERIAL. THE TOP SIDE OF THE DRAPE WAS UNAFFECTED. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND CONFIRMED TO MEET ALL MANUFACTURING AND QUALITY SPECIFICATIONS, WITH NO REWORK OR SPECIAL CONDITIONS REPORTED. PEST CONTROL AND FUMIGATION PLANS ARE IN PLACE, INCLUDING MONTHLY PERIMETER AND COMMON AREA TREATMENTS, AIR CURTAINS IN PRODUCTION CELLS, AND LIGHT TRAPS AROUND THE DOCK TO PREVENT INSECT INTRUSION. THE FUMIGATION PROGRAM COVERS RODENTS, FLYING INSECTS, BIRDS, AND OTHER PESTS. FOREIGN MATERIALS AND STAINS ON PACK 77769-80 SHOW A DOWNWARD TREND, WITH THIS BEING THE FIRST INCIDENT REPORTED BETWEEN FEBRUARY 2024 AND FEBRUARY 2026. PERSONNEL IN THE CUTTING AREA WERE INFORMED OF THE INCIDENT FOR AWARENESS. 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

    THE PRODUCT INVOLVED IN THIS COMPLAINT IS SAID TO BE AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE 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.

    Description of Event or Problem · 0

    A 62-YEAR-OLD PATIENT WAS ADMITTED FOR CREATION OF A RIGHT-WRIST RADIOCEPHALIC ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, FOREIGN MATERIAL WAS OBSERVED CONTAMINATING THE STERILE FIELD, PRESENTING A POTENTIAL CONTAMINATION RISK. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392465 HALYARD U-BAR PACK VII SURGICAL DRAPES AND PACKS LRO O&M HALYARD, INC. 77769 AC2513201A 30680651777691

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown