Monoject 8881225299Recalls & reported problems
Cardinal Health, Inc. · Blood Collection/Infusion Set,Multi-Sample Luer Adapter, 12 inch (30.5 cm) Tubing · Class 2
All models of Monoject (164)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521013353), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2021Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THEIR STANDARD 21G BUTTERFLY NEEDLES WERE TEMPORARILY REPLACED WITH THE MONOJECT BLOOD COLLECTION 21G X 3/4". WITH THIS PARTICULAR MODEL THEY HAVE NOTICED IT CAN COME UNSHEATHED VERY EASILY AND MAY CAUSE A NEEDLE STICK. THE CUSTOMER STATED THAT THEY PULLED OUT A KIT TO DO A BLOOD DRAW ON A PATIENT AND NOTICED THE PLASTIC THAT COVERED THE NEEDLE PULLED THE SHEATH AND SAFE TIED THE NEEDLE BEFORE THEY COULD DO ANYTHING WITH IT. THEY BROUGHT THIS ISSUE TO THE CHARGE NURSE AT THE TIME AND WHEN THEY EXAMINED THE PRODUCT THEY FELT THIS WOULD BE A VERY EASY WAY FOR SOMEONE TO ACCIDENTALLY POKE THEMSELVES. THE CUSTOMER STATED THAT NO ONE WAS HURT BY THIS PRODUCT BUT THEY FELT THE NEED TO REPORT IT BEFORE SOMEONE DID. THE CUSTOMER ALSO STATED THAT THE VACUTAINER ATTACHMENT FALLS OFF FROM THE NEEDLE / TUBING. ALL PRODUCT WAS PULLED AND WILL NOT BE USED. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 18-JAN-2021 STATED THAT WHEN THEY WENT TO PULL OFF THE CLEAR PLASTIC THAT COVERS THE NEEDLE, IT WOULD ENGAGE THE SAFETY MECHANISM AND THE NEEDLE WOULD DISENGAGE. THEY COULD MANUALLY PUSH THE NEEDLE BACK SO THAT THEY WERE ABLE TO USE THE PRODUCT BUT THIS POS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11193284 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page