BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL EENT IV PACK 5

    MDR report key: 21218853 · Received January 23, 2025

    Report

    Report Number
    3005997949-2025-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Report Date
    February 26, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651887192
    PMA / PMN Number
    K083234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). AN INVESTIGATION WAS PERFORMED THAT INCLUDED A REVIEW OF SAMPLE PICTURES AND THE DEVICE HISTORY RECORD (DHR). THE PICTURES REVEALED EMBEDDED DIRT ON THE DRAPE. NO ABNORMALITIES WERE FOUND IN THE DHR, THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS FOR RELEASE. THERE WAS NO REWORK CONDUCTED DURING LOT MANUFACTURE. PROCESS REVIEW DID NOT IDENTIFY ANY SOURCES OF DUST PARTICLES DURING MANUFACTURING. CLEANING AND SANITIZATION PROCEDURES WERE VERIFIED, CONFIRMING THAT SURFACES ARE CLEANED AT THE START OF EACH SHIFT AND FLOORS ARE CLEANED DAILY OR AS NEEDED. THE MANUFACTURING LINE WAS NOTIFIED OF COMPLAINT FOR AWARENESS. SITE WILL CONTINUE TO TRACK AND TREND COMPLAINTS TO DETERMINE IF CORRECTIVE ACTIONS ARE WARRANTED. 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 NOT AVAILABLE FOR EVALUATION. 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

    DURING THE PLACEMENT OF THE HEAD SHEET, THE SURGEON REALIZED THE SHEET WAS COVERED WITH DUST, COMPROMISING STERILITY. THERE WAS A 20-MINUTE DELAY TO THE START OF SURGERY. NEW ASEPSIS AND ANTISEPSIS PROTOCOLS WERE PERFORMED TO PREVENT CONTAMINATION IN THE SURGERY ROOM TO PROTECT THE PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931596 SURGICAL EENT IV PACK 5 SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 88719 AC2418703D 30680651887192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown