Halyard 97021Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20680651970217), received between Mar 30, 2017 and Aug 19, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2019 AND WAS TRANSFERRED TO ICU [INTENSIVE CARE UNIT] ON (B)(6) 2019 AND PLACED ON VENTILATOR. THE PATIENT'S TONGUE BEGAN TO DEVELOP SWELLING A "FEW DAYS LATER" AND [THE PATIENT] ALSO DEVELOPED A LOW GRADE FEVER. HOSPITAL STAFF TOOK [THE PATIENT] OFF THE "ANTI-PLAQUE" MOUTHWASH AND STARTED [THE PATIENT] ON A STEROID ON (B)(6) 2019. HOSPITAL STAFF IS NOW KEEPING [THE PATIENT'S] MOUTH MOIST WITH DISTILLED WATER AND THE SWABS. HOSPITAL STAFF HAS STARTED WEANING [THE PATIENT] OFF THE VENTILATOR AND [THE PATIENT] WILL BE GOING TO REHAB WHEN EXTUBATED. NO LONGER HAS FEVER. NO OTHER SYMPTOMS OTHER THAN THE TONGUE SWELLING AND LOW GRADE FEVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Fever; Swelling

  MAUDE report 8906994 ↗
• MalfunctionJan 12, 2018Break

  WHILE PERFORMING MOUTH CARE ON AN INTUBATED PATIENT, THE SWAB SNAPPED WHEN THE PATIENT CLOSED THEIR MOUTH. SPONGE TIP RETRIEVED WITH YANKAUER, AND KELLY CLAMP FROM BACK OF PATIENT'S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185346 ↗
• MalfunctionNov 13, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUCTION SWAB CAME OFF SUCTION SWAB STICK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026705 ↗
• MalfunctionNov 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THERE WAS AN ISSUE TODAY IN WHICH THE REGISTERED NURSE WAS PERFORMING MOUTH CARE AND DURING CARE, THE SPONGE FELL OFF THE DEVICE AND WAS IN THE PATIENT'S AIRWAY. PER THE RESPIRATORY THERAPIST, THE PATIENT'S MOUTH WAS SWOLLEN WHICH MADE IT VERY DIFFICULT TO LOCATE THE SPONGE. THEY WERE ABLE TO REMOVE IT, BUT IT TOOK APPROXIMATELY 15 MINUTES AND REQUIRED THE RESPIRATORY THERAPIST AND THE PHYSICIAN ASSISTANT." ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2017 THAT STATES, "THE PATIENT¿S SWOLLEN MOUTH WAS A RESULT OF INJURY FROM A SUICIDE ATTEMPT, NOT DUE TO EFFORTS TO RETRIEVE THE SWAB. THE CUSTOMER WAS COMPLETELY SEDATED ON A VENTILATOR WITH AN ENDOTRACHEAL TUBE IN PLACE. THERE WAS NO PATIENT INJURY AND NO DESATURATION." A BITE BLOCK WAS IN PLACE. NO DENTITION ISSUES NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7014833 ↗
• MalfunctionApr 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN ISSUE WAS REPORTED WITH THE ORAL CARE KITS (Q4 HOUR KIT) AND (Q4 HOUR KIT WITH CHG) THE REPORT STATES, WHERE THE TWO KITS WERE STOCKED NEXT TO EACH OTHER AS PREVIOUSLY DONE WITH THE SAGE KITS, BUT THE HALYARD KITS ARE THE SAME COLOR/SIMILAR PACKAGING AND WAS MISTAKEN AS ONE FOR THE OTHER. THE SITE WHERE THIS ISSUE CAME FROM IS REVIEWING/AND POTENTIALLY ATTRIBUTING AS A CAUSE TO PATIENT DEVELOPING VENTILATOR-ASSOCIATED PNEUMONIA (VAP). ADDITIONAL INFORMATION WAS RECEIVED ON 22-MARCH-2017 THAT CONFIRMED THERE IS ONLY ONE PATIENT INVOLVED THAT DEVELOPED VAP. ADDITIONAL INFORMATION WAS RECEIVED ON 24-MARCH-2017 PROVIDED THE PATIENT¿S DEMOGRAPHICS AND THE DATE PLACES ON THE VENTILATOR AS (B)(6) 2017. THE VAP WAS DIAGNOSED (B)(6) 2017. THE PATIENT PRESENTED 101 TEMPERATURE ON (B)(6) 2017 THE TEMPERATURE WAS 103.6. AN INCREASE IN FRACTION OF INSPIRED OXYGEN (FI02), PEEP, AND TRACHEAL ASPIRATE SHOWED STAPH AUREUS ON (B)(6) 2017. IT WAS BELIEVED THAT THE PATIENT ASPIRATED PRIOR TO INTUBATION AT THE HOSPITAL. THE HEALTHCARE WORKER ALSO STATED THAT THE ELECTRONIC MEDICAL RECORD SHOWS THAT CHLORHEXIDINE (CHG) WAS USED ON THIS PATIENT EVERY DAY THEY WERE IN THE HOSPITAL. AN OVERRIDE WAS DONE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6472815 ↗
• MalfunctionMar 30, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2017-00040 FOR THE FIRST REPORT. IT WAS REPORTED THAT, TWO DIFFERENT NURSES REPORTED THAT THE SWAB CAME APART AND WAS IN THE PATIENT'S MOUTH. NO INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446955 ↗
• MalfunctionMar 30, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2017-00041 FOR THE SECOND REPORT. IT WAS REPORTED THAT, TWO DIFFERENT NURSES REPORTED THAT THE SWAB CAME APART AND WAS IN THE PATIENT'S MOUTH. NO INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446950 ↗