Monoject 1188827112Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521007444), received between Sep 9, 2019 and Sep 2, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component

  It was reported that the physician inserted a 27G 1 1/2" Monoject standard hypodermic needle to provide local anesthetic and when the needle was removed, there was no needle on the hub. Additional information received on 05 AUG 2026 stated that that the needle was retained in the patient and based on follow up CT scan it was deemed unsafe to remove. On (b)(6) 2026 it was stated that the needle is in the patient's lung parenchyma. The patient has been discharged from the hospital.

  Patient problems: Foreign Body In Patient

  MAUDE report 50567869 ↗
• MalfunctionApr 4, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT THE 27-GAUGE NEEDLES ARE SUPPOSED TO LOCK ONTO THE SYRINGES AND THEY DON¿T LOCK. THEY KEEP SPINNING WHEN THEY PUT THEM ONTO THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED ON 18MAR2022, THERE WASN¿T ANY HARM DONE. THEY USED A DIFFERENT NEEDLE THEY HAD PURCHASED PREVIOUSLY AND THERE WERE NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998842 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT THE 27-GAUGE NEEDLES ARE SUPPOSED TO LOCK ONTO THE SYRINGES AND THEY DON¿T LOCK. THEY KEEP SPINNING WHEN THEY PUT THEM ONTO THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED ON 18MAR2022, WHILE ADMINISTERING THE INJECTION, THE NEEDLE WAS IN THE PATIENT¿S FOOT AND BECAUSE THE NEEDLE COULDN¿T LOCK ON COMPLETELY, THE PRESSURE FROM THE LIQUID BEING PUSHED THROUGH THE NEEDLE FROM THE SYRINGE CAUSING THE NEEDLE TO BE PUSHED OFF OF THE SYRINGE. THIS RESULTED IN THE FLUID THAT WAS IN THE SYRINGE TO SPRAY OUT OF THE SYRINGE INSTEAD OF GOING INSIDE THE PATIENT¿S FOOT AS INTENDED. THERE WASN¿T ANY HARM DONE. THEY USED A DIFFERENT NEEDLE THEY HAD PURCHASED PREVIOUSLY AND THERE WERE NO PROBLEMS. THE SYRINGE USED WAS A 3RD PARTY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998812 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT THE 27-GAUGE NEEDLES ARE SUPPOSED TO LOCK ONTO THE SYRINGES AND THEY DON¿T LOCK. THEY KEEP SPINNING WHEN THEY PUT THEM ONTO THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, WHILE ADMINISTERING THE INJECTION, THE NEEDLE WAS IN THE PATIENT¿S FOOT AND BECAUSE THE NEEDLE COULDN¿T LOCK ON COMPLETELY, THE PRESSURE FROM THE LIQUID BEING PUSHED THROUGH THE NEEDLE FROM THE SYRINGE CAUSING THE NEEDLE TO BE PUSHED OFF OF THE SYRINGE. THIS RESULTED IN THE FLUID THAT WAS IN THE SYRINGE TO SPRAY OUT OF THE SYRINGE INSTEAD OF GOING INSIDE THE PATIENT¿S FOOT AS INTENDED. THERE WASN¿T ANY HARM DONE. THEY USED A DIFFERENT NEEDLE THEY HAD PURCHASED PREVIOUSLY AND THERE WERE NO PROBLEMS. THE SYRINGE USED WAS A 3RD PARTY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998810 ↗
• InjuryAug 26, 2021Break; Break

  THE CUSTOMER REPORTED THAT THEY HAD A NEEDLE BREAK AND IT LODGED IN THE PATIENT¿S BACK.

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 12374525 ↗
• MalfunctionNov 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO THE DISTRIBUTOR THAT THE DEVICE WILL NOT LOCK INTO THE SYRINGE; THE NEEDLE BLOWS OFF THE SYRINGE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE ISSUE HAPPENED DURING CASE-SET UP. THE CUSTOMER FURTHER STATED THAT WHEN THEY ATTEMPT TO PUT THE NEEDLE ON THE SYRINGE IT DOES NOT LOCK. THEY TRIED SEVERAL NEEDLES AND SYRINGE COMBINATIONS AND IT WAS ALWAYS THE NEEDLE THAT HAD THE PROBLEM.

  Patient problems: No Patient Involvement

  MAUDE report 9318582 ↗
• MalfunctionSep 9, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  THE CUSTOMER REPORTED THAT THE NEEDLES HAVE A LEAK. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE LOCKING PART OF THE NEEDLE DOES NOT LOCK ON TO THE SYRINGE AND CAUSES LEAKING. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976684 ↗