Monoject 8881225307Recalls & reported problems
Cardinal Health, Inc. · Blood Collection/Infusion Set,Multi-Sample Luer Adapter, 12 inch (30.5 cm) Tubing · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521013391), received between Apr 30, 2017 and Feb 25, 2021 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem3
- Fail-Safe Did Not Operate2
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH PULL TAB. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN THE NURSES ARE DONE WITH THE COLLECTION, THEY PULL THE TABS TO SECURE THE NEEDLE AND IF THEY PUSH ON THE BUTTERFLY IT ALLOWS THE NEEDLE TO RELEASE FROM THE PIECE OF METAL THAT IS SUPPOSED TO HOLD IT. THE NURSE HAS NOTICED THAT THE SAFETY ON THIS BUTTERFLY IS FAILING. THE CUSTOMER FURTHER STATED THAT IT APPEARS TO BE THE PIECE OF METAL THAT IS SUPPOSED TO HOLD THE NEEDLE AFTER USE IS NOT PROPERLY BENT TO CONTAIN THE NEEDLE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382183 ↗MalfunctionFeb 25, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH PULL TAB. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN THE NURSES ARE DONE WITH THE COLLECTION, THEY PULL THE TABS TO SECURE THE NEEDLE AND IF THEY PUSH ON THE BUTTERFLY IT ALLOWS THE NEEDLE TO RELEASE FROM THE PIECE OF METAL THAT IS SUPPOSED TO HOLD IT. THE NURSE HAS NOTICED THAT THE SAFETY ON THIS BUTTERFLY IS FAILING. THE CUSTOMER FURTHER STATED THAT IT APPEARS TO BE THE PIECE OF METAL THAT IS SUPPOSED TO HOLD THE NEEDLE AFTER USE IS NOT PROPERLY BENT TO CONTAIN THE NEEDLE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382098 ↗MalfunctionMar 24, 2020Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER STATED THAT THEY ARE HAVING ISSUES WITH THE SAFETY DEVICE STAYING LOCKED BACK AND THE WINGED PART WAS TOO FLEXIBLE AND NOT STURDY ENOUGH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874318 ↗InjuryApr 30, 2017Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER STATES THAT THE PRODUCT DOES NOT ENGAGE IT ALSO BECAME LOOSE AND ONE NEEDLE GOT STUCK.
Patient problems: Needle Stick/Puncture
MAUDE report 6533107 ↗InjuryApr 30, 2017Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTS THAT THE SAFETY DEVICE ON THE BUTTERFLY WILL NOT ENGAGE, AND WHEN IT DOES ENGAGE, THE DEVICE COMES LOOSE CAUSING THE NEEDLE TO STICK. ONE NEEDLE STUCK AFTER USE. THE CUSTOMER FURTHER STATES THAT THE PRODUCT DOES NOT ENGAGE; IT ALSO BECAME LOOSE AND ONE NEEDLE GOT STUCK.
Patient problems: Needle Stick/Puncture
MAUDE report 6533093 ↗
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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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