Monoject 8881401056Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884521002863), received between Jul 25, 2019 and Sep 10, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 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.

• MalfunctionSep 10, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT WHEN THE CAP OF THE NEEDLE WAS PULLED OFF WHITE POWDER CAME OUT AND APPEARS THAT IT WAS ON THE NEEDLE ALSO.

  Patient problems: No Patient Involvement

  MAUDE report 8983003 ↗
• InjurySep 10, 2019Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE NEEDLES ARE FALLING APART AND NOT STAYING TOGETHER, ONE NEEDLE GOT STUCK ON THE PATIENT'S CHEEK. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE DOCTOR USED HIS RIGHT HAND TO INJECT THE ANESTHETIC AND WHEN THE NEEDLE GOT SEPARATED FROM THE METAL HUB, HE GRABBED THE HUB PART AND PULLED IT OUT. THE PATIENT WAS NOT AWARE THE INCIDENT HAPPENED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8981433 ↗
• MalfunctionJul 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT THERE IS WHITE POWDER ON THE NEEDLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826776 ↗