BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK PFR95 FS SMALL

    MDR report key: 17076067 · Received June 6, 2023

    Report

    Report Number
    9616096-2023-00028
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Report Date
    June 6, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    MSH
    UDI-DI
    30680651468278
    PMA / PMN Number
    K974068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF SIXTEEN (16) SAMPLES WERE RECEIVED IN THE FOLLOWING GROUPING: THIRTEEN (13) KIMBERLY CLARK BRANDED MASKS, TWO (2) O&M HALYARD, INC. BRANDED MASKS, ONE (1) HALYARD HEALTH INC. BRANDED MASK AND ONE (1) EMPTY KIMBERLY CLARK PRODUCT BOX FOR LOT NUMBER A J608317C WAS RECEIVED. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE THIRTEEN (13) KIMBERLY CLARK BRANDED SAMPLES WERE LAID OUT ON THE LAB TABLE. THE BLUE ELASTIC HEAD BANDS APPEAR STUCK TOGETHER AND WAVY. SIX (6) OF THESE SAMPLES WERE INSPECTED MORE CLOSELY. THE ELASTIC HEADBANDS WERE GIVEN A TUG AS IF FOR DONNING. THE HEADBANDS ON ONE SAMPLE DETACHED FROM THE CORNER BOND. THE ELASTIC OF ALL THE SAMPLES DID NOT RETRACT. ONE (1) HALYARD HEALTH, INC. BRANDED SAMPLE ARRIVED WITH THE LEFT (AS WORN) ELASTIC COMPLETELY DETACHED FROM THE CORNER BOND. THE ELASTIC DOES NOT APPEAR TO BE DAMAGED AT THE BOND AREA. THERE IS NO RESIDUAL ELASTIC INSIDE THE BOND AREA OF THE LEFT SIDE. THE HEADBANDS APPEAR SECURELY ATTACHED TO THE RIGHT SIDE CORNER BOND AREA. TWO (2) O&M HALYARD, INC.SAMPLES WERE INSPECTED. THE ELASTIC HEAD BANDS WERE GIVEN A TUG AS IF FOR DONNING. NO DETACHMENT OCCURRED ON EITHER SAMPLE. THE ELASTIC REMAINED SECURELY ATTACHED TO THE INSIDE OF THE CORNER BOND AREAS. THIS PRODUCT IS OVER 14 YEARS OLD FROM THE LOT PROVIDED. CODE 46827 MENTIONED IN COMPLAINT HAS A SHELF LIFE OF 5 YEARS. THEREFORE THIS PRODUCT HAS EXPIRED. A POTENTIAL ROOT CAUSE IS PRODUCT HAD EXPIRED AND THERE IS MATERIAL DEGRADATION AS A RESULT. 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.

    Description of Event or Problem · 0

    A NURSE WHO WAS IN A COVID POSITIVE ROOM AT (B)(6) UNIVERSITY WAS WEARING ONE OF HALYARD'S N95 MASKS WHEN THE STRAP BROKE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188922 MASK PFR95 FS SMALL ICP FACIAL PROTECTION PRODUCTS MSH O&M HALYARD, INC. 46827 J608317C 30680651468278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown