Monoject 11832115 (UDI 10884521544543)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521544543), received between Mar 20, 2020 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fluid/Blood Leak1
- Fracture1
Patient problems
- Intraoperative Cardiac Valve Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED: THE CUSTOMER REPORTED THAT THE RN USED THE NEW SYRINGES TO DRAW UP TORADOL FOR A PATIENT, WENT TO ADMINISTER THE MEDICATION AND IT SHOT OUT THE SIDE OF THE HUB AND DIDN'T INJECT. THE RN STATED THIS IS THE 3RD TIME SHE HAS HAD ONE OF THE NEW SYRINGES BREAK. SHE STATED THAT USUALLY IF THEY BREAK, ITS WHEN THEY TIGHTEN THE NEEDLE ON THE END, IT BREAKS THE LUER LOCK AND THE NEEDLE POPS OFF.
Patient problems: Intraoperative Cardiac Valve Injury
MAUDE report 22035544 ↗MalfunctionMar 20, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THE CUSTOMER REPORTED THAT WHEN THE DOCTOR WAS PERFORMING AN INJECTION ON A PATIENT, THE SYRINGE BEGAN TO LEAK DURING ADMINISTRATION OF THE LIDOCAINE. UPON FURTHER EVALUATION, A CRACK WAS DISCOVERED IN THE BODY OF THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9860484 ↗
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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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