BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD FLUIDSHIELD LEVEL 3 FOG-FREE SURGICAL MASK

    MDR report key: 21619361 · Received March 17, 2025

    Report

    Report Number
    9616096-2025-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    December 23, 2024
    Report Date
    April 29, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651482076
    PMA / PMN Number
    K111402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT IS 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.

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WAS RECEIVED INSIDE A PLASTIC BAG. TOGETHER WITH THE MASK, ORANGE FIBER STRANDS WERE INSIDE THE PLASTIC BAG. THE MAJORITY OF THE ORANGE FIBER STRANDS ARE LOOSE; HOWEVER, THERE ARE SOME STRANDS THAT ARE BONDED ON THE LEFT SIDE (AS WORN) OF THE MASK SEAM. THERE WERE FIFTEEN (15) UNUSED SAMPLES RECEIVED FOR EVALUATION. ONE (1) MASK CONTAINS A PIECE OF RED TAPE WHICH IS ADHERED TO THE OUTSIDE OF THE MASK. THE APPEARANCE IS THE MATERIAL WAS SPLICED IN THAT AREA AND THE RED TAPE WAS INCLUDED IN THE MANUFACTURING OF THAT MASK. THE OTHER FOREIGN MATERIALS ARE MENTIONED IN THE EVALUATION ABOVE AS LOOSE FIBERS. A DEVICE HISTORY RECORD (DHR) REVIEW OF COMPLAINT LOT WAS PERFORMED. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION. SAMPLING PLAN WAS DETERMINED USING THE ANSI/ASQZ 1.4 TO RELEASE THE PRODUCT. VISUAL INSPECTION IS PERFORMED BASED ON AQL 1.0 LEVEL S-4. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS, THEN RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. AS PART OF FACILITY CLEANING PROCESSES, SURFACES ARE CLEANED WITH 70% IPA MINIMALLY ONCE PER SHIFT. A COMPLAINT TREND ANALYSIS WAS PERFORMED FOR PAST 12 MONTHS, FROM JANUARY 2024 TO JANUARY 2025. THERE HAVE BEEN NO UPWARD TRENDS DURING THE PAST 12 MONTHS FOR THIS ISSUE. NOTIFICATION OF COMPLAINT WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. A QUALITY ALERT WAS POSTED IN THE MANUFACTURING AREA TO NOTIFY PERSONNEL INVOLVED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(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

    A PHYSICIAN HAD DEBRIS FALL FROM THEIR MASK ONTO STERILE FIELD. THE STERILE FIELD HAD TO BE DRAPED AGAIN. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT. THIS INCIDENT OCCURRED PRIOR TO USE WITH A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186628 HALYARD FLUIDSHIELD LEVEL 3 FOG-FREE SURGICAL MASK ICP FACIAL PROTECTION PRODUCTS FXX O&M HALYARD, INC. 48207 AM4260331 30680651482076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown