Monoject 8881400074Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521002746), received between Oct 17, 2019 and Oct 4, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 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.

• MalfunctionOct 4, 2021Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTS THAT THE CAPS POP OFF THE SYRINGE IN THE MIDDLE OF FREEZING; WILL NOT SCREW IN PROPERLY. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ISSUE IS NOT WITH THE CAP OR THE SHEATH BUT THAT THE NEEDLE IS SUPPOSED TO SCREW INTO THE SYRINGE BUT IT WAS NOT THREADING OR CATCHING PROPERLY. THERE DIDN¿T SEEM TO BE ANY THREADING ON THE NEEDLE. THE COLORED END WOULD NOT STAY ON THE SYRINGE. THEY ARE USING A MILTEX SYRINGE SELF ASP 1.8CC METAL. THIS ISSUE OCCURRED DURING PATIENT USE WHILE FREEZING THE PATIENT. IT OCCURRED ONE TIME. NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572482 ↗
• MalfunctionFeb 10, 2021Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTER THAT THE DENTAL NEEDLE IS NOT FITTING PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310509 ↗
• MalfunctionNov 7, 2019Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TIPS OF THE DEVICE ARE BREAKING OFF. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290267 ↗
• InjuryOct 17, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE NEEDLE CLEANLY DETACHED FROM THE HUB WHILE IN USE. THE DOCTOR REMOVED THE NEEDLE FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9204991 ↗
• InjuryOct 17, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER STATED THE NEEDLE CLEANLY DETACHED FROM THE HUB WHILE IN USE. THE DOCTOR REMOVED THE BROKEN TIP FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9204764 ↗