Monoject 8881200441Recalls & 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
- 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 30884521008643), received between Oct 15, 2019 and Jul 18, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak3
- Connection Problem2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- 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.
MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED 3 NEEDLES WERE LEAKING AT THE CONNECTION SITE. ADDITIONAL INFORMATION RECEIVED STATED THEY WERE LEAKING FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17341764 ↗MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHEN THEY TRY TO TAKE THE CAP OFF THE NEEDLE, IT'S BREAKING AT THE HUB. BASED ON THE PICTURE RECEIVED FROM THE CUSTOMER, IT WAS OBSERVED THAT THE NEEDLE WAS DETACHED FROM THE HUB. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE NEEDLE WAS ALREADY SEPARATED, WHICH WAS DISCOVERED BEFORE USE WHEN GETTING READY TO TRIGGER POINT INJECTIONS IN OFFICE AND ONE HAD NO NEEDLE AT ALL. THE CUSTOMER FURTHER CONFIRMED THAT THERE WAS NO NEEDLE BENT OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12049126 ↗MalfunctionJan 6, 2020Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
THE CUSTOMER REPORTED THAT THE NEEDLE WAS LEAKING AT THE HUB WHERE THEY CONNECTS WITH THE SYRINGE. THE ISSUE WAS NOTICED DURING INJECTION, WHICH AFFECTS THE APPROPRIATE AMOUNT OF MEDICATION BEING INJECTED TO THE PATIENT. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT INVOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9554171 ↗MalfunctionJan 6, 2020Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
THE CUSTOMER REPORTED THAT THE NEEDLE WAS LEAKING AT THE HUB WHERE THEY CONNECTS WITH THE SYRINGE. THE ISSUE WAS NOTICED DURING INJECTION, WHICH AFFECTS THE APPROPRIATE AMOUNT OF MEDICATION BEING INJECTED TO THE PATIENT. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT INVOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9554123 ↗MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT A MONOJECT HYPODERMIC ALUMINUM NEEDLE 25 G DETACHED YESTERDAY WHILE INITIATING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9191395 ↗
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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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