Monoject 8881106028Recalls & reported problems
Cardinal Health, Inc. · 6 mL Syringe,Regular Tip · Class 2
All models of Monoject (164)
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 10884521013896), received between May 29, 2019 and Oct 2, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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
- Crack2
- Fluid/Blood Leak2
- Leak/Splash2
- Material Puncture/Hole2
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2019Crack; Leak/Splash; Crack; Leak/Splash
THE CUSTOMER REPORTED THAT THERE IS A CRACK IN THE SYRINGE. WHEN THERE IS INCREASED PRESSURE ON THE PLUNGER, WATER STREAMED FROM THE AREA OF THE CRACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9146778 ↗MalfunctionOct 2, 2019Crack; Leak/Splash; Crack; Leak/Splash
THE CUSTOMER REPORTED THAT THERE IS A CRACK IN THE SYRINGE. WHEN THERE IS INCREASED PRESSURE ON THE PLUNGER, WATER STREAMED FROM THE AREA OF THE CRACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9146366 ↗MalfunctionJun 12, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTS THE SYRINGE WAS BEING USED TO INFLATE A BALLOON WITH A MIXED LIQUID HOWEVER, THE MIXED LIQUID WAS JUST LEAKING OUT OF THE SYRINGE BECAUSE OF A HOLE NEAR THE GRADUATION MARKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8693235 ↗MalfunctionMay 29, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTS THE SYRINGE WAS BEING USED TO INFLATE A BALLOON WITH A MIXED LIQUID HOWEVER, THE MIXED LIQUID WAS JUST LEAKING OUT OF THE SYRINGE BECAUSE OF A HOLE NEAR THE GRADUATION MARKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8650023 ↗
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- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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- 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.
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