BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN XL

    MDR report key: 20567440 · Received October 30, 2024

    Report

    Report Number
    9680646-2024-00010
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 9, 2024
    Report Date
    February 17, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FYA
    UDI-DI
    30680651417344
    PMA / PMN Number
    K192362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PRODUCT CASE WAS OPENED IN THE LAB AND ALL THIRTY (30) PRODUCT PACKAGES WERE OPENED. A SUBJECTIVE OLFACTORY ASSESSMENT WAS PERFORMED ON THESE SAMPLES. NO ODOR WAS DETECTED APART FROM WHAT WAS DESCRIBED AS STANDARD PLASTIC SMELL FROM NONWOVENS. ONE WEEK LATER, THE THIRTY (30) PRODUCT PACKAGES WERE REMOVED FROM THE SAME OPEN CASE AND A SUBJECTIVE OLFACTORY ASSESSMENT WAS PERFORMED. THERE WAS AN ODOR DETECTED ON SOME OF THE ALREADY OPEN PRODUCT PACKAGES. THE ODOR DETECTED CAN BE DESCRIBED AS A MUSTY OR MOLDY ODOR. OTHERS IN THE OFFICE PERFORMED A SUBJECTIVE OLFACTORY ASSESSMENT ON THESE SAME SAMPLES. THE ODOR DETECTED WAS OFFENSIVE TO SOME AND WAS DESCRIBED AS MUSTY OR MOLDY. THE SECOND CASE OF PRODUCT WAS OPENED IN THE LAB. TWO (2) GOWN PACKAGES WERE OPENED. SUBJECTIVE OLFACTORY ASSESSMENT FOUND ODOR PRESENCE DESCRIBED AS MOLDY OR MUSTY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND CONFIRMED PRODUCT WAS MANUFACTURED AND RELEASED PER SPECIFICATIONS. EO AND ECH (ETHYLENE CHLOROHYDRIN) VALUES ARE BELOW THE ANSI/AAMI ISO 10993-7 REQUIREMENT AND PRODUCT REQUIREMENTS. BASED ON THESE RESULTS, EO AND ECH RESIDUALS DID NOT LIKELY CONTRIBUTE TO THE ODOR. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GCMS) WITH THERMAL DESORPTION TESTING WAS PERFORMED AT ROOM TEMPERATURE AND ALSO AT INCREASED TEMPERATURE BY A THIRD-PARTY TESTING LABORATORY. THE TEST IDENTIFIED TWO POTENTIAL CHEMICALS WHICH COULD CAUSE POTENTIAL ODORS (GALAXOLIDE AND ALPHA HEXYLCINNAMYL ALDEHYDE). O&M HAS DETERMINED THESE WERE NOT THE LIKELY SOURCE OF ODOR. NO ROOT CAUSE WAS 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 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS RETURNED AND PENDING EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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 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 STRONG CHEMICAL SMELL WAS REPORTED BY THE CUSTOMER COMING FROM THE HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN, XL. ONE STAFF MEMBER REQUIRED MEDICAL EVALUATION; TREATMENT DETAILS REMAIN UNKNOWN. THE SMELL APPEARS TO BE LIMITED TO THE GOWN AND LOT. THE ENTIRE LOT ASSOCIATED WITH THIS GOWN HAS BEEN QUARANTINED BY THE CUSTOMER. ON (B)(6) 2024, A RESPONSE WAS RECEIVED FROM THE CUSTOMER THAT STATES THERE WAS NO DELAY IN SURGICAL OR EMERGENCY PROCEDURES. THE PRODUCT WAS SHIPPED TO (B)(6) CLINIC BY A DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042216 HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN XL SURGICAL GOWNS STERILE FYA O&M HALYARD, INC. 41734 AH4217TU6 30680651417344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other