Halyard 97020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20680651970200), received between Sep 19, 2017 and Dec 22, 2017 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2017Disconnection; Disconnection

  IT WAS REPORTED THE SPONGE CAME OFF IN THE PATIENT'S MOUTH. THE DEVICE WAS RETRIEVED BY THE CLINICIAN WITHOUT INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141509 ↗
• InjuryDec 15, 2017Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MEDICAL ASSISTANT IN THE DOCTOR'S OFFICE ON 15 JAN 2018. THE MEDICAL ASSISTANT CONVEYED THAT THE PHYSICIAN REPORTED THAT THE LACERATION WAS DUE TO AGGRESSIVE SUCTIONING. HOWEVER, THE PHYSICIAN WAS NOT PRESENT WHEN THE INJURY OCCURRED, NOR WAS THE OBSERVATION DOCUMENTED IN THE CHART. THE INTENSIVE CARE UNIT NURSE MANAGER WAS UNABLE TO VERIFY HOW THE LACERATION OCCURRED AS SHE WAS NOT SURE HOW IT HAPPENED OR WHO WAS RESPONSIBLE FOR PERFORMING MOUTH CARE. THE MEDICAL ASSISTANT STATED THAT 6 STITCHES WERE MADE TO THE SOFT PALATE OF THE PATIENT'S MOUTH BY THE PHYSICIAN.

  Patient problems: Laceration(s)

  MAUDE report 7122263 ↗
• MalfunctionOct 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NURSE WAS PERFORMING ORAL CARE ON AN INTUBATED PATIENT, AND THE SUCTION SWAB'S FOAM FELL OFF INSIDE THE PATIENT'S MOUTH. THE NURSE WAS ABLE TO RETRIEVE A PIECE OF FOAM BEFORE GOING DOWN THE AIRWAY. THERE WAS NO ADVERSE OUTCOME REPORTED BY THE HOSPITAL, NO INJURY REPORTED TO THE PATIENT, AND NO MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6963304 ↗
• MalfunctionSep 21, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TOOLS FALLING OFF OF HANDLE DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6884737 ↗
• MalfunctionSep 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, "NURSING STAFF REPORTED SPONGE END FALLING OFF AND INTO THE PATIENT'S MOUTH." ADDITIONAL INFORMATION HAS BEEN REQUESTED BY NOT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875590 ↗