Halyard 46827Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 20680651468271), received between May 5, 2020 and Aug 1, 2023 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 9, 2023Open, Classified

   One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

   Z-2626-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Break; Break

  THE STRAPS ARE BREAKING OFF AT THE CORNER OF THE MASK, AND COMING UNDONE DURING USE. THE CORNER IS NOT GLUED. THE MASKS ARE USED IN COVID+ ROOMS DURING PT/OT/SLP SESSIONS. THE MASKS BREAK DURING INITIAL THIRTY MINUTES OF USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435620 ↗
• MalfunctionJul 3, 2023Break; Break

  THE N95 DUCK-TYPE MASKS ARE BREAKING. IT WAS REPORTED THIS OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252970 ↗
• MalfunctionJul 3, 2023Break; Break

  OUR NURSING LEADER(S) STATED SMALL DUCKBILL MASKS (PRODUCT CODE: 46827) ARE BREAKING. THE MASK ARE TEARING (TWO LAYERS SEPARATED AT CORNERS) WHERE THE MASKS AND ELASTIC JOIN. SOME NURSES WERE STAPLING THE MASKS AT THE CORNERS. IT WAS REPORTED THIS OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247851 ↗
• MalfunctionJun 29, 2023Break; Break

  CUSTOMER REPORTED 15 OR MORE INDIVIDUALS HAVE ISSUED COMPLAINTS AROUND THE N95 STRAPS DETACHING FROM THE CORNER. IT WAS REPORTED THIS OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232090 ↗
• MalfunctionJun 27, 2023Break; Break

  STRAPS BROKE UPON DONNING THE MASK. MOST ISSUES OCCURRED WHILE DONNING, BUT THERE HAVE BEEN REPORTS OF MASKS FALLING APART WHILE BEING WORN (DURING USE). 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208639 ↗
• MalfunctionJun 27, 2023Break; Break

  "WE HAVE A DEFECTIVE BATCH OF THE SMALL KIMBERLY CLARK N95 MASKS. EVERY TIME SOMEONE TRIES TO DON THE MASK THE STRAPS ARE EASILY RIPPING". MOST ISSUES OCCURRED WHILE DONNING, BUT THERE HAVE BEEN REPORTS OF MASKS RIPPING (DURING USE). 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208523 ↗
• MalfunctionJun 27, 2023Break; Break

  STRAPS BREAKING PRIOR TO USE. ONE OCCURENCE HAPPENED WHILE STAFF WAS PERFORMING DUTIES IN PATIENT'S ROOM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208516 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THE EARLOOP WERE BREAKING AWAY ON THE SMALL N95 MASKS. TWO STAFF MEMBERS REPORTED THE SMALL N95 RUBBER BAND PART ON LEFT SIDE KEPT BREAKING. THE STAFF WENT THROUGH A NUMBER OF MASKS BEFORE GETTING ONE THAT DID NOT BREAK. INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167942 ↗
• MalfunctionJun 20, 2023Break; Break

  N95 ELASTIC BANDS DID NOT HOLD UP AND BECAME LIKE SPAGHETTI. INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167919 ↗
• MalfunctionJun 20, 2023Break; Break

  INNER LINING OF MASK NOT ATTACHED AT SEAM ON ONE SIDE OF MASK. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163608 ↗
• MalfunctionJun 19, 2023Break; Break

  STRAPS ON MASKS EASILY BREAK CAUSING PROVIDERS TO USE MULTIPLE MASKS IN ONE SHIFT. SOME STRAPS HAVE BROKEN WHILE PROVIDERS ARE IN THE MIDDLE OF CARING FOR PATIENTS WHILE WEARING THE MASK (STRAPS POP OFF), PRESENTING A POSSIBLE EXPOSURE RISK. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153648 ↗
• MalfunctionJun 19, 2023Break; Break

  WE HAVE EXPERIENCED BOTH REGULAR AND SMALL SIZES BREAKING IN THE STRAP AREA CONNECTED TO THE MASK. INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151987 ↗
• MalfunctionJun 16, 2023Break; Break

  THE ELASTIC STRAPS SEEM TO BE FAULTY WITHIN THE MASK AS THEY KEPT SNAPPING. MULTIPLE MASKS WERE TRIED TO NO AVAIL. THE PRODUCT INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148611 ↗
• MalfunctionJun 16, 2023Break; Break

  THE NURSING STAFF INDICATED THAT THE BANDS ON THE N95 MASKS ARE SNAPPING. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148605 ↗
• MalfunctionJun 16, 2023Break; Break

  THERE WERE MULTIPLE BREAKING POINTS ON THE STRAPS. A RESIDENT REPORTED THE STRAP BROKE ON 2 DIFFERENT MASKS. THIS INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148593 ↗
• MalfunctionJun 16, 2023Break; Break

  STRAPS BREAKING ON N95 MASKS NOTICED BY CUSTOMER. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142114 ↗
• MalfunctionJun 15, 2023Separation Problem; Separation Problem

  "I RECENTLY GOT A BOX OF FLUIDSHIELD 3 N95 PARTUCULATE FILTER RESPIRATOR AND SURGICAL MASKS FOR MY DEPARTMENT'S USE. FOR SOME ODD REASON, THIS PARTICULAR LOT# (AM0301811) HAS VERY WEAKLY FASTENED STRAPS THAT POP FREE OF THE MASK WITH THE SLIGHTEST PRESSURE. THEY ARE FASTENED INTO THE SIDES OF THE MASK MUCH, MUCH WEAKER THAN WHAT I AM NORMALLY USED TO WITH THIS MASK. I'VE WORN THE SAME MASK, BUT A DIFFERENT LOT BEFORE AND NEVER HAD THE STRAPS POP LOOSE LIKE THIS BEFORE. THEY ARE POPPING LOOSE FROM THE MASK ON ONE SIDE WHILE JUST SITTING THERE WEARING THEM." THIS INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140846 ↗
• MalfunctionJun 15, 2023Break; Break

  THIS MORNING, NURSING HAS BROUGHT BACK SMALL N95 MASKS WITH THE STRAPS PULLED AWAY FROM THE CORNER OF THE MASKS. RUBBER BANDS ON N95 BREAK DURING USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140834 ↗
• MalfunctionJun 15, 2023Break; Break

  THE CUSTOMER REPORTED THE STRAPS BROKE DURING USE. ADDITIONAL DETAILS OF INCIDENT HAVE BEEN REQUESTED, HOWEVER, NOT PROVIDED BY THE REPORTER. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17140588 ↗
• MalfunctionJun 9, 2023Break; Break

  THE MASKS EXHIBITED THE FOLLOWING ISSUES; MISSING HEADBANDS, HEADBANDS BREAKING/DETACHING, HOLE IN THE MASK MATERIAL, MASK DUCKBILL PORTION SEPARATING/NOT SEALED, INNER LAYERS COMES APART. THE CUSTOMER STATED A CLINICIAN IN THE EMERGENCY ROOM WAS WORKING WITH A PATIENT AND NOTICED A HOLE IN THE MASK. THE CLINICIAN WAS CONCERNED ABOUT EXPOSURE TO COVID-19. THE CLINICIAN DID NOT REPORT ANY INJURY, TESTING PERFORMED, SYMPTOMS, OR OTHER MEDICAL INTERVENTION PERFORMED. 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. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101746 ↗
• MalfunctionJun 9, 2023Break; Break

  THE CUSTOMER UTILIZES THE MASKS WHEN SEEING WALK-IN PATIENTS WITH RESPIRATORY SYMPTOMS AND TO PERFORM COVID TESTS. THE CUSTOMER REPORTED THE HEADBAND BREAKING OFF. NORMALLY WEARS ONE MASK A DAY BUT WITH THIS ONE MASK IT WAS REPLACED THREE TIMES A DAY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101721 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076067 ↗
• MalfunctionJun 6, 2023Break; Break

  THE BAND ACTUALLY PULLED AWAY FROM THE MASK (IN A COVID ROOM). A LEVEL ONE COVER WAS BEING UTILIZED OVER THE TOP TO HOLD THE MASK IN PLACE. THERE HAVE BEEN OTHER INSTANCES WHERE THE BANDS BROKE TRYING TO PUT ON MASK OR BROKE AFTER THEY PUT THE MASK ON. 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. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076058 ↗
• MalfunctionMay 8, 2023Break; Break

  INCIDENT ONE. THE STRAPS WERE POPPING OFF AT THE SEAMS WHEN DONNING THE SMALL N95 MASK. IN LESS THAN A WEEK, WE ALSO HAD 2 INCIDENTS WHERE THE MASK BROKE WHILE IN A COVID PATIENTS ROOM. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16885576 ↗
• MalfunctionMay 8, 2023Break; Break

  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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16885505 ↗