Monoject 1180320112Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Standard Hypodermic Needle · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521012325), received between Jan 22, 2020 and Jan 22, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Crack” (5 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
Device problems
- Crack5
- Fluid/Blood Leak4
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2020Crack; Leak/Splash; Crack; Leak/Splash
THE CUSTOMER REPORTED THE DEVICE WAS LEAKING DUE TO CRACKS IN THE BODY OF THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9618578 ↗MalfunctionJan 22, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THE SYRINGE WAS LEAKING DUE TO CRACKS IN THE BODY OF THE SYRINGE. THIS WAS NOTICED IN THE RHEUMATOLOGY DEPARTMENT AS THEY WERE ADMINISTERING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9618010 ↗MalfunctionJan 22, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING ADMINISTERING, LEAKING WAS NOTICED DUE TO CRACKS IN THE BODY OF THE SYRINGE. THIS WAS HAPPENED IN THE RHEUMATOLOGY DEPARTMENT. THERE WAS NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9616192 ↗MalfunctionJan 22, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING ADMINISTERING, LEAKING WAS NOTICED DUE TO CRACKS IN THE BODY OF THE SYRINGE. THIS WAS HAPPENED IN THE RHEUMATOLOGY DEPARTMENT. THERE WAS NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9616091 ↗MalfunctionJan 22, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THE DEVICE WAS LEAKING DUE TO CRACKS IN THE BODY OF THE SYRINGE. THIS WAS NOTICED IN THE RHEUMATOLOGY DEPARTMENT WHILE ADMINISTERING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9615617 ↗
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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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