BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK PFR95 FS SMALL

    MDR report key: 16885505 · Received May 8, 2023

    Report

    Report Number
    9616096-2023-00025
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Report Date
    May 15, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR (4) SAMPLES ARRIVED WITH A DETACHED ELASTIC HEAD BAND. THE EVALUATIONS ARE AS FOLLOWS: SAMPLE1: THE HEAD BAND IS DETACHED FROM THE RIGHT SIDE (AS WORN) THERE IS NO DAMAGE OBSERVED ON THE BLUE ELASTIC BOND POINTS. THERE IS NO RESIDUE OF BLUE ELASTIC INSIDE THE CORNER BOND AREA. ONE OF THE HEAD BANDS IS TORN IN THE CENTER. WHERE THE ELASTIC IS TORN, THERE IS THE APPEARANCE OF A ROUNDED EDGE. HALF OF ROUNDED EDGE CORRESPONDS TO THE OPPOSITE TORN SIDE AND A BLACKENED SUBSTANCE IS OBSERVED ON THE ELASTIC. IT IS NOT CLEAR WHAT WOULD HAVE CREATED THIS ROUND APPEARANCE. THE OPPOSITE CORNER BOND WAS INSPECTED. THE ELASTIC APPEARS SECURELY BONDED INSIDE THAT CORNER BOND AREA. SAMPLE 2: THE HEAD BAND IS DETACHED FROM THE RIGHT SIDE (AS WORN) THERE IS NO DAMAGE OBSERVED ON THE BLUE ELASTIC BOND POINTS. THERE IS NO RESIDUE OF BLUE ELASTIC INSIDE THE CORNER BOND AREA. THE TWO BANDS ARE STUCK TOGETHER IN ONE SPOT WHERE A BLACKENED EDGE IS OBSERVED. THERE IS A SMALL PIECE MISSING FROM THE BAND IN THIS SPOT. THE OPPOSITE CORNER BOND WAS INSPECTED. THE ELASTIC APPEARS SECURELY BONDED INSIDE THAT CORNER BOND AREA. SAMPLE 3:THE HEAD BAND IS DETACHED FROM THE LEFT SIDE (AS WORN). THERE IS NO DAMAGE OBSERVED ON THE BLUE ELASTIC BOND POINTS. THERE IS NO RESIDUE OF BLUE ELASTIC INSIDE THE CORNER BOND AREA. THE OPPOSITE CORNER BONDS WAS INSPECTED. THE LAYERS AT THE CORNER BOND ARE SEPARATED HOWEVER THE BLUE ELASTIC IS STILL ATTACHED TO THAT CORNER BOND. SAMPLE 4: THE HEAD BAND IS DETACHED FROM THE LEFT SIDE (AS WORN). THERE IS NO DAMAGE OBSERVED ON THE BLUE ELASTIC BOND POINTS. THERE IS NO RESIDUE OF BLUE ELASTIC INSIDE THE CORNER BOND AREA. THE OPPOSITE CORNER BOND WAS INSPECTED. THE ELASTIC APPEARS SECURELY BONDED INSIDE THE CORNER BOND AREA. A REVIEW OF DHR PRODUCTION RECORDS WAS COMPLETED. PULL STRENGTH HEADSTRAP TESTS ARE CONDUCTED PER SPECIFICATION REQUIRING 4.0LBS PERFORMANCE STRENGTH. THE RECORDS FROM THIS LOT SHOW AVERAGE OF 7.3LBS (WITHIN SPECIFICATION). DOCUMENTED RECORDS SHOW ALL VISUAL AND FUNCTIONAL INSPECTIONS WERE WITHIN SPECIFICATIONS AND THERE WERE NO NONCONFORMANCES DOCUMENTED DURING PRODUCTION OF THE COMPLAINT LOT. 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, 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

    THE STRAPS ON THE N95 MASK WERE BREAKING WHILE THE CLINICIANS ARE PUTTING THEM ON OR SOON AFTER. ONE BROKE WHILE THE NURSE WAS IN WITH A PATIENT WHO HAD COVID19. 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
    725949 MASK PFR95 FS SMALL ICP FACIAL PROTECTION PRODUCTS MSH O&M HALYARD, INC. 46827 AM0178811 30680651468278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown