Monoject 8881512977 (UDI 10192253030686)Recalls & reported problems
Cardinal Health 200, LLC · Control Syringe Luer-Lock Tip · Class 2
All models of Monoject (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253030686), received between Nov 13, 2023 and Jul 8, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Break; Break
THE CUSTOMER REPORTED THAT THE TIP BROKE OFF INSIDE THE NEEDLE EXTENDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689941 ↗MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE 12CC SYRINGE WAS SPRAYING OUT OF THE BACK. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942362 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN PROVIDER USES SYRINGE TO ADMINISTER MEDICATION, IT IS COMING OUT OF THE TOP SIDE OF SYRINGE (NO PROPER SEAL ON SYRINGE). ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 15NOV2023 STATED THAT IT APPEARS THE PLUNGER DOES NOT SEAL TO THE SYRINGE AND FLUID IS ABLE TO BYPASS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18238725 ↗MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE PROVIDER USES THE SYRINGE TO ADMINISTER MEDICATION IT IS COMING OUT OF THE TOP SIDE OF THE SYRINGE, NO PROPER SEAL ON THE SYRINGE. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE AFFECTED QUANTITY OR THE EXACT LOT(S) STATING THAT THE PRODUCT IS SPREAD THROUGHOUT THEIR FACILITY AND THIS HAS BEEN A CONTINUAL ISSUE WITH THESE FOR A LONG PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18126943 ↗
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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.
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