Monoject 8881401072Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521002906), received between May 23, 2019 and Sep 15, 2021 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Break; Break

  THE CUSTOMER REPORTED THAT A MONOJECT NEEDLE BROKE IN THE PATIENT¿S MOUTH DURING A PROCEDURE. THE NEEDLE SEPARATED THE UPPER LEFT VESTIBULE AND THE PATIENT REQUIRED SURGERY TO REMOVE IT. THE PATIENT HAD TO BE SENT TO A HOSPITAL BECAUSE THE NEEDLE COULD NOT BE REMOVED BY THE DENTIST OR ORAL SURGEON WITHOUT POSSIBLY CAUSING SERIOUS DAMAGE. THE DOCTOR SAID HE WASN¿T DOING ANYTHING DIFFERENT THAN USUAL DURING HIS 15 YEARS OF DENTISTRY. IT WAS A ROUTINE ANESTHETIZING ON A (B)(6) YEAR-OLD FEMALE. THE DENTIST USED A 30-GAUGE SHORT MONOJECT NEEDLE AND WAS DOING THE UPPER AND LOWER LEFT. HE GAVE A LOWER LEFT BLOCK WHICH WENT FINE. HE THEN GAVE AN UPPER LEFT INJECTION TO THE #14, 15 AREA AND THE INJECTION WENT SMOOTHLY WITH NO MOVEMENT NOR JUMPING FROM THE PATIENT. WHEN HE PULLED OUT FROM THE MOUTH, HE SAW THAT THE WHOLE NEEDLE FROM THE HUB DOWN, WAS GONE. BY THIS POINT THE PATIENT HAD CLOSED HER MOUTH. WHEN HE HAD HER OPEN HER MOUTH BACK UP, HE DID NOT SEE ANY OF THE NEEDLE. HE IMMEDIATELY TOOK AN X-RAY TO CONFIRM AND SAW THAT THE NEEDLE WAS INSIDE THE PATIENT¿S MOUTH. HE SENT THE PATIENT TO (B)(6) AND WAS NOTIFIED BY THE PATIENT¿S LAWYER TO SEND PATIENT RECORDS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 12477852 ↗
• MalfunctionFeb 4, 2020Break; Break

  THE CUSTOMER REPORTED THE NEEDLE BROKE DURING A PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664284 ↗
• MalfunctionSep 9, 2019Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE NEEDLES ARE FALLING APART AND NOT STAYING TOGETHER. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 30-AUG-2019 STATED THAT THE NEEDLES ARE FALLING APART AT THE METAL HUB DURING USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977860 ↗
• MalfunctionMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE NEEDLES COME OFF WHEN TAKING THE CAP OFF. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637355 ↗