Monoject 8881200508Recalls & reported problems
Cardinal Health, Inc. · Standard Hypodermic Needle,Aluminum Hub · Class 2
Data updated Oct 13, 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 30884521008704), received between Dec 23, 2019 and Mar 6, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- 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.
MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT TWO PODIATRISTS ARE HAVING ISSUES WITH THE YELLOW 27 GAUGE NEEDLES. THEY HAVE HAD SEVERAL THAT LEAK. ON (B)(6) 2024 THE CUSTOMER STATED THAT ONE PROVIDER STATED THAT THEY CAN ONLY RECALL 1 OR 2 INSTANCES OF LEAKING AT THE LEVEL OF THE LUER LOCK. ADDITIONAL INFORMATION RECEIVED ON 06MAR2024 STATED THAT IT SEEMS LIKE IT IS LEAKING FROM THE NEEDLE HUB. THEY ARE USING BD PLASTIPAK 3 ML SYRINGE LUER-LOCK TIP, LOT 3321046. ITEM NUMBER UNKNOWN. THE ISSUE IS OCCURRING WHEN INJECTING. NO HARM OTHER THAN THE PATIENT GETTING POKED A SECOND TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18848064 ↗MalfunctionJan 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGES ARE LEAKING ON THE SIDES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11233526 ↗MalfunctionJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE 27G NEEDLE LEAKS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118712 ↗MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE STANDARD HYPODERMIC NEEDLE IS LEAKING INJECTION FLUID AROUND THE ALUMINUM HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9510782 ↗
Other Needle, hypodermic, single lumen devices
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- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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