Monoject 1180600555Recalls & reported problems
Cardinal Health, Inc. · 6 mL Syringe,Regular 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 10884521013568), received between Jun 18, 2019 and Oct 12, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break3
- Fluid/Blood Leak1
Patient problems
- Exposure to Body Fluids1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2022Break; Break
THE CUSTOMER REPORTED THAT WHILE USING THE DEVICE IN AN EXTENSION, THE TIP (WHICH DOES NOT HAVE A LUER TIP, IT HAS A SMOOTH TIP ENDING) BROKE OFF. THIS OCCURRED IN THE ED. NO INJURIES WERE REPORTED. PER ADDITIONAL INFORMATION PROVIDED ON OCTOBER 06, 2022, THEY REMOVED THE EXTENSION SET AND REPLACED IT. NO ADVERSE EVENTS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587991 ↗MalfunctionOct 12, 2022Break; Break
THE CUSTOMER REPORTED THAT WHILE USING THE SYRINGE IN A TRANSFER DEVICE, THE TIP (WHICH DOES NOT HAVE A LUER TIP, IT HAS A SMOOTH TIP ENDING) BROKE OFF. THIS OCCURRED IN THE ED. NO INJURIES WERE REPORTED. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THEY WERE TAKING THE SYRINGE AND CONNECTING IT TO A VACUTAINER AND THE TIP OF THE SYRINGE BROKE WHICH CAUSED BLOOD TO SPLASH ON THE PATIENT, NURSE, AND ROOM. NO ADVERSE EVENTS OCCURRED.
Patient problems: Exposure to Body Fluids
MAUDE report 15587978 ↗MalfunctionJun 18, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THERE IS A MOON-SHAPED SLIT NEAR THE TIP OF THE SYRINGE THAT IS CAUSING LEAKAGE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8709131 ↗
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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 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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