BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM LOWER EXTR DRAPE 130

    MDR report key: 19557125 · Received June 18, 2024

    Report

    Report Number
    3005997949-2024-00007
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Report Date
    July 16, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651132322
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON THE 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE COMPLAINT LOT NUMBER. THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. REVIEW OF COMPLAINT PHOTO ONE FOCUSED ON A PORTION OF THE ABSORBENT MATERIAL ALONG A BACK TABLE COVER WITH THE FILM SIDE UP. A GLOVED FINGER POINTS TO THE UPPER SECTION OF THE ABSORBENT MATERIAL TO DENOTE SOME RAISED FIBERS. PHOTO TWO SHOWS A ZOOMED SECTION FROM THE PREVIOUS IMAGE, THIS IMAGE SHOWED AN ANGLE THAT THE RAISED FIBERS ARE CLEARER. RIGHT BELOW THE GLOVED FINGER, THE AREA LOOKS ABRADED. A ROOT CAUSE WAS NOT IDENTIFIED. 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 AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    FIBERS WERE COMING OFF OF DRAPE. THE CLINICIAN WAS PERFORMING A ORTHOPEDIC PROCEDURE USING GUIDEWIRES AT TIME OF DISCOVERY. THE CLINICIAN WAS CONCERNED ABOUT PATIENT RISK OF HAVING FIBERS INSERTED IN VESSELS. NO PATIENT INJURY OR ADDITIONAL TREATMENT WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322189 CUSTOM LOWER EXTR DRAPE 130 SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 13232 AC23142201 30680651132322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown