Monoject 8881202017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521082892), received between Feb 2, 2021 and Apr 23, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CUSTOMER REPORTS: ON THE MED-SURG FLOOR, A NIGHT SHIFT NURSE REPORTED TO THE MANAGER THAT THE 18 GAUGE BLACK BLUNT NEEDLES THAT WERE BEING SUPPLIED TO DRAW UP MEDICATIONS WERE FAULTY AND ACTUALLY ALLOWED PIECES OF THE MEDICATION VIAL RUBBER TOP TO GET INTO THE SYRINGE ITSELF. THERE IS NO HARM TO ANY PATIENT SINCE IT WAS NOTICED BEFORE THE SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717387 ↗
• MalfunctionApr 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTS: AN ELDERLY FEMALE WAS BEING TREATED FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ON THE INPATIENT MEDICAL FLOOR. WHEN THE RN WAS DRAWING UP SOLU-MEDROL USING A BLUNT NEEDLE (18 GAUGE, GRAY, MONOJET), A PIECE OF THE RUBBER STOPPER WAS ABLE TO BE DRAWN INTO THE SYRINGE. THE SUPERVISOR WAS NOTIFIED. NO HARM TO PATIENT BECAUSE IT WAS DISCOVERED BY THE NURSE PRIOR TO ADMINISTERING THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694427 ↗
• MalfunctionApr 19, 2021Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THROUGH MEDWATCH THAT THE RN COMPLAINED THAT THE NEEDLES WERE LEAVING TINY PIECES OF RUBBER IN THE SYRINGE. THE RN STATED THAT SHE WAS DOUBLE CHECKING HER MEDICATION WHEN SHE NOTICED A TINY PIECE OF RUBBER IN THE MEDICATION. THE RN ALSO NOTICED THAT THE NEEDLES WERE FLAT, NOT BEVELED, CAUSING A PUNCH OUT OF THE RUBBER SEAL EACH TIME THEY WERE USED. THE PUNCH OUT LOGGED INTO THE NEEDLE AND GETS SUCKED INTO THE SYRINGE WITH THE MEDICATION. THE RN IMMEDIATELY WENT TO ALL FLOORS AND ADVISED THE SUPERVISOR TO REMOVE THESE NEEDLES FROM THEIR STOCK. THE STAFF WERE ADVISED TO SEARCH FOR ANY PLACE WHERE BLUNT NEEDLES ARE USED TO MAKE SURE THAT NONE ARE MISSED. THE STOCK ROOM WAS ADVISED TO NOT RESTOCK THIS PRODUCT. THE NEXT SHIFT WAS ADVISED OF THE ISSUE AND ALL STAFF WERE TOLD NOT TO RESTOCK THIS ITEM IF ANY MORE WERE FOUND. THERE WAS NO HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685359 ↗
• MalfunctionFeb 16, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED THE CLINICAL STAFF NOTICED PIECES OF MATERIAL INSIDE THE SYRINGE AFTER THE CANNULA WAS USED TO PULL MEDICATION. THE INJECTION/ IV PUSH WAS NOT ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332556 ↗
• MalfunctionFeb 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THE NURSE WAS USING THE BLUNT NEEDLE TO DRAW MEDICATION. SHE HAD TO PUSH EXTRA HARD INTO THE MEDICATION VIAL AND NOTICED A PIECE OF THE TOP OF THE VIAL HAD GONE INTO HER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266836 ↗