Monoject 1180600777 (UDI 10884521013582)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521013582), received between Jul 15, 2019 and Mar 4, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2021Filling Problem; Filling Problem

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417705 ↗
• MalfunctionMar 4, 2021Filling Problem; Filling Problem

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417691 ↗
• MalfunctionMar 4, 2021Filling Problem; Filling Problem

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417631 ↗
• MalfunctionMar 4, 2021Filling Problem; Filling Problem

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417618 ↗
• MalfunctionMar 4, 2021Filling Problem; Filling Problem; Gas/Air Leak

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417487 ↗
• MalfunctionMar 4, 2021Filling Problem; Filling Problem

  THE CUSTOMER REPORTED THE PHLEBOTOMISTS ARE COMPLAINING THAT THE MONOJECT 6ML SYRINGES ARE GIVING A SMALL INITIAL RETURN, BUT THEN PULLING AIR WHILE THE NEEDLE IS STILL INSIDE THE VEIN. IT SEEMS THE SYRINGE MAY HAVE A GAP AT THE RUBBER STOPPER THAT IS PULLING AIR IN WHEN THE PLUNGER IS PULLED BACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417399 ↗
• MalfunctionJun 19, 2020Nonstandard Device; Nonstandard Device

  THE CUSTOMER STATED THAT THEY HAVE EXCESS BUBBLING WHEN USING THE 6ML SYRINGE TO DRAW UP BLOOD. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174265 ↗
• MalfunctionApr 27, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT IT WAS DIFFICULT TO REMOVE MINUTE AIR BUBBLES AND HARD TO MEASURE ACCURACY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10001379 ↗
• MalfunctionFeb 18, 2020Fluid/Blood Leak; Structural Problem; Fluid/Blood Leak; Structural Problem

  THE CUSTOMER REPORTED THAT WHILE IN THE ED, THE NURSE PULL BACK ON THE PLUNGER OF THE SYRINGE TO WITHDRAW BLOOD, THEN THE BLOOD SPRAYED THROUGH THE BACK SIDE OF THE SYRINGE AND SPLASHED TO THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-FEB-2020 STATING THAT THE PLUNGER SEEMS TO BE TOO SMALL FOR THE CANNULA AND THE SEAL WAS POOR. THE NURSE HAD A DIRECT SKIN EXPOSURE TO THE PATIENT'S BLOOD. THE NURSE WAS NOT HARMED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722507 ↗
• MalfunctionOct 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS THAT THE PRODUCT WAS DRAWING AIR INSTEAD OF BLOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202038 ↗
• MalfunctionOct 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS THAT THE PRODUCT WAS DRAWING AIR INSTEAD OF BLOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174703 ↗
• MalfunctionOct 4, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT THE AIR IS ENTERING INTO THE SYRINGE WITH THE BLOOD SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158664 ↗
• MalfunctionOct 4, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT AIR IS ENTERING INTO THE SYRINGE WITH THE BLOOD SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158634 ↗
• MalfunctionSep 24, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS THAT THE PRODUCT WAS DRAWING AIR INSTEAD OF BLOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109016 ↗
• MalfunctionAug 19, 2019Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT SYRINGE IS LOSING SUCTION AND AIR IS LEAKING INTO THE TUBE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8905956 ↗
• MalfunctionJul 31, 2019Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT THE SYRINGE WAS LOSING SUCTION AND LEAKING AIR INTO THE TUBE. THEY HAD TO REDRAW THE SAMPLE, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846236 ↗
• MalfunctionJul 15, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT WHEN PULLING BACK ON THE SYRINGE THE BLOOD IS BUBBLING AND COMING THROUGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8790124 ↗