Q-Care 6464Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00618029830777), received between Aug 1, 2019 and Jan 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. IT WAS REPORTED THAT ¿WHILE DOING ORAL CARE THE SPONGE CAME OFF THE SWAB. IT BECAME LODGE IN THE PATIENT'S THROAT.¿ LOT INFORMATION WAS PROVIDED. THE AFFECTED SUCTION SWAB WAS RETURNED FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED, INCLUDING INFORMATION ABOUT ADVERSE CONSEQUENCES OR WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218129 ↗
• MalfunctionNov 7, 2019Material Separation; Material Separation

  REPORT RECEIVED OF A MALFUNCTION RESULTING IN A SUCTION ORAL SWAB DISENGAGEMENT. ORAL CARE WAS PERFORMED BY A NURSE ON A PATIENT WHO WAS UNABLE TO FOLLOW COMMANDS. THE REPORTER STATED THE PATIENT BIT DOWN ON THE SUCTION ORAL SWAB STRAW CAUSING THE STRAW AND GREEN FOAM TO DISENGAGE INSIDE THE PATIENT'S MOUTH. REPORTER STATED THE DISENGAGED STRAW AND GREEN FOAM WERE SUCCESSFULLY RETRIEVED AND NO INJURY OCCURRED. THE REPORTED ISSUE OCCURRED DURING INITIAL USE OF THE DEVICE AND NO BITE BLOCK WAS IN USE DURING THE REPORTED ISSUE. THE DEVICE WAS DISCARDED, HOWEVER, A PHOTOGRAPH WAS AVAILABLE. NO LOT INFORMATION WAS PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9294050 ↗
• MalfunctionAug 1, 2019Material Separation; Material Separation

  RECEIVED MEDSUN REPORT FROM FDA. PER REPORT, "WHILE USING SAGE KIT FOR MOUTH CARE ON VENTILATOR, THE SWAB BROKE OFF INTO PATIENTS MOUTH. I REACHED INTO HIS MOUTH TO REMOVE THE SWAB. NO HARM TO PATIENT." REPORT REF# (B)(4). ATTEMPTING TO CONTACT REPORTER TO GATHER ADDITIONAL DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8852473 ↗