BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FOG SURGICAL MASK GREEN 50

    MDR report key: 12774785 · Received November 8, 2021

    Report

    Report Number
    9616096-2021-00002
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 11, 2021
    Report Date
    December 3, 2021
    Manufacturer
    OWENS & MINOR HALYARD INC.
    Product Code
    FXX
    UDI-DI
    30680651492358
    PMA / PMN Number
    K823078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    O&M HALYARD, INC. RECEIVED A COMPLAINT RELATED TO HALYARD* ANTI-FOG SURGICAL MASK, PRODUCT CODE 49235 ON (B)(6), 2021. A SURGEON REPORTED THAT HIS LOOPS KEPT FOGGING UP DURING A PROCEDURE AND ACCUMULATED MOISTURE DRIPPED ONTO THE SURGICAL SITE. THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. SINCE NO LOT NUMBER WAS PROVIDED, A PROCESS AND MATERIALS INVESTIGATION WERE CONDUCTED FOR THE MOST RECENT LOT PRODUCED FOR PRODUCT CODE 49235 AND NO ASSIGNABLE ROOT CAUSE WAS IDENTIFIED. RECORDS DEMONSTRATE THAT THE PRODUCT IS MANUFACTURED ACCORDING TO THE SPECIFICATION. THE INCOMING INSPECTION PROCESS INCLUDES AN ASSESSMENT OF THE POLYETHYLENE ANTI FOG MATERIAL AND FILM POLYETHYLENE MATERIAL. THE MATERIALS ARE ANALYZED ACCORDING TO THE INCOMING INSPECTION REQUIREMENTS WHICH REQUIRE A CERTIFICATE OF CONFORMANCE. IN ADDITION, A QUALITY NON-CONFORMANCE RECORD WAS INITIATED TO REVIEW THE DESIGN AND DIMENSIONAL CHARACTERISTICS OF THE MASK TO DETERMINE IF THE DESIGN MAY HAVE CONTRIBUTED TO THE USER EXPERIENCE. THE FMEA IN THE RISK MANAGEMENT FILE IDENTIFIES FOGGING AND CONDENSATION AS AN IMPROBABLE OCCURRENCE WITH A LOW RISK LEVEL. THIS IS CONSISTENT WITH THE RESULTS OF THE COMPLAINT TREND FOR PRODUCT CODE 49235 AND FAILURE MODE CONDENSATION. ALL INFORMATION REASONABLY KNOWN AS OF 14DEC2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. 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 AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED BY THE SURGEON WHO WAS USING THE AGREED UPON GREEN MASK FROM HALYARD TODAY AND HIS LOUPES KEPT FOGGING UP. THIS IS A CRITICAL SAFETY ISSUE AS BEING IN THE MIDDLE OF A PROCEDURE AND NOT BEING ABLE TO SEE COULD BE CATASTROPHIC TO THE PATIENT. I KNOW THAT WE SEEM TO HAVE ADAPTED TO THE HALYARD MASK, BUT I AM NOW HEARING THAT THERE HAVE BEEN ISSUES. THE ONES WITH THE PLASTIC ON THE OUTSIDE TEND TO ACCUMULATE MOISTURE FROM THE REBREATHING AND THIS DEVELOPS TO THE POINT THAT IT DRIPS ONTO THE FIELD. NO OTHER TREATMENT WAS NOTED. THIS RESIDUE CAUSES BREAKOUTS AND RASHES ON STAFF. ALL INFORMATION REASONABLY KNOWN AS OF 08NOV2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON WAS USING THE AGREED UPON GREEN MASK FROM HALYARD TODAY AND HIS LOUPES KEPT FOGGING UP. THIS IS A CRITICAL SAFETY ISSUE AS BEING IN THE MIDDLE OF A PROCEDURE AND NOT BEING ABLE TO SEE COULD BE CATASTROPHIC TO THE PATIENT. I KNOW THAT WE SEEM TO HAVE ADAPTED TO THE HALYARD MASK, BUT I AM NOW HEARING THAT THERE HAVE BEEN ISSUES. THE ONES WITH THE PLASTIC ON THE OUTSIDE TEND TO ACCUMULATE MOISTURE FROM THE REBREATHING AND THIS DEVELOPS TO THE POINT THAT IT DRIPS ONTO THE FIELD. THIS RESIDUE CAUSES BREAKOUTS AND RASHES ON STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667533 ANTI-FOG SURGICAL MASK GREEN 50 ICP FACIAL PROTECTION FXX OWENS & MINOR HALYARD INC. 49235 UNKNOWN 30680651492358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown