Monoject 8881112083 (UDI 10884521010895)Recalls & reported problems
Cardinal Health, Inc. · 12 mL Syringe,Luer-Lock Tip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521010895), received between Dec 2, 2019 and Jun 2, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination1
- Contamination /Decontamination Problem1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2021Contamination; Contamination
THE CUSTOMER REPORTED A 12CC MONOJECT SYRINGE WAS FOUND WITH PLASTIC FRAGMENTS INSIDE THE BARREL OF THE SYRINGE. THE PLUNGER WAS IN PLACE. THE CUSTOMER STATED THE SYRINGE HAD BEEN USED WITH WATER, BUT THE FRAGMENTS WERE TOO LARGE TO FIT THROUGH THE OPENING SO THEY DO NOT APPEAR TO HAVE BEEN INTRODUCED DURING USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11925926 ↗MalfunctionJul 9, 2020Particulates
CUSTOMER REPORTS: PARTICULATE AND HAIRS FOUND IN 12 ML NON STERILE SYRINGES. ADDITIONAL INFORMATION RECEIVED STATES THAT SOME OF THE PARTICULATE WAS FREE FLOATING.
Patient problems: No Patient Involvement
MAUDE report 10252735 ↗MalfunctionDec 2, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THERE WAS A HAIR FOUND IN THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9397290 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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