Monoject 8881513223 (UDI 20192253037774)Recalls & reported problems
Cardinal Health 200, LLC · 3 mL Syringe with Standard Hypodermic Needle · Class 2
All models of Monoject (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20192253037774), received between May 10, 2024 and Jan 13, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak9
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE RUBBER STOPPER ON THE END OF THE PLUNGERS ON THE INSIDE OF THE SYRINGES ARE NOT SEATED CORRECTLY. SOME ARE NOT ATTACHED, OR SIDEWAYS. FLUID LEAKS OUT OF THEM AND THEY ARE UNABLE TO USE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143242 ↗MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGES HAVE NO SUCTION AND ARE LEAKING PAST THE BLACK RUBBER AND IT IS VERY DIFFICULT TO GET PLASTIC CASING OFF AND PLUNGERS ARE TOO TIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469986 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGES HAVE NO SUCTION AND ARE LEAKING PAST THE BLACK RUBBER AND IT IS VERY DIFFICULT TO GET PLASTIC CASING OFF AND PLUNGERS ARE TOO TIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452267 ↗MalfunctionOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A CRACKED SYRINGE. ADDITIONAL INFORMATION RECEIVED ON 26SEP2024 CONFIRMED THERE WAS LEAKING FROM THE CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344996 ↗MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE BARREL IS CRACKED AND TECH NOTICED AS SHE WAS DRAWING UP A FLUSH. THE SLEEVE (RIGID PACK) IS PERFECT, NO PUNCTURES, NO CRACKS ETC. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATED THAT THE TECHNICIAN NOTICED THE CRACK BECAUSE IT (THE FLUSH) STARTED TO COME OUT OF THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295532 ↗MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USED THE 3ML SYRINGE TO DRAW UP CYTOPOINT FOR A PET. THEY USED A 30MG VIAL AND TWO 40MG VIALS HOWEVER 1 ML OF THE MEDICATION LEAKED OUT AROUND THE SYRINGE, DESPITE BEING TIGHTLY ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20159210 ↗MalfunctionAug 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY DREW UP CYTOPOINT AND THE WHOLE THING WAS WASTED BECAUSE IT WAS LEAKING OUT OF THE SIDE, THE SYRINGE BARREL HAD A CRACK. THE CUSTOMER STATED THEY DID NOTICE A SMALL DENTED AREA IN THE RIGID PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20054402 ↗MalfunctionAug 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A CRACKED SYRINGE BARREL. THE DOCTOR DREW UP THE INJECTION AND IT CAME OUT OF THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20049113 ↗MalfunctionJul 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED, THAT THREE, SO FAR OUT OF THE BOX CRACKED DOWN SYRINGE. ADDITIONAL INFORMATION RECEIVED ON 29JUL2024. STATED, THAT THE CRACK WENT MORE THAN HALF WAY DOWN THE BARREL. THE SYRINGE LEAKED OUT WHATEVER WAS DRAWN UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19860612 ↗MalfunctionMay 10, 2024Break; Break
THE CUSTOMER REPORTED THAT THE SYRINGE IS A LUER LOCK SYRINGE AND THE PLASTIC PIECE THE NEEDLE SITS ON IS MISSING. THE CUSTOMER DESCRIBED IT AS BEING IN THE HUB AREA, NEEDLE CAN'T SET ON SYRINGE PROPERLY. A PHOTO WAS PROVIDED WHICH APPEARS TO SHOW THE INNER LUER BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293759 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page