Monoject 8881892950Recalls & reported problems
Cardinal Health 200, LLC · Monoject Magellan 1/2mL Insulin Safety Syringe Permanent Needle 29G x1/2 in. (0.33 x 13 mm) · Class 2
- 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 10192253025538), received between Aug 7, 2025 and Aug 7, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE NURSING FLOOR HAS HAD ACCIDENTAL NEEDLESTICK INCIDENTS INVOLVING SYRINGE MODEL 8881892950, ALL DISPENSED BY PHARMACY FOR LONG-ACTING INSULIN ADMINISTRATION. THE CORE SAFETY CONCERN IS THAT THE NEEDLE GUARD ON THIS SYRINGE DOES NOT ENGAGE SMOOTHLY. INITIALLY, IT SLIDES UP AND APPEARS TO STOP, WHICH CAN GIVE THE IMPRESSION THAT THE NEEDLE IS FULLY COVERED. HOWEVER, NURSES NEED TO APPLY ADDITIONAL FORCE BEYOND THIS INITIAL RESISTANCE TO FULLY ACTIVATE THE SAFETY GUARD AND PROPERLY COVER THE NEEDLE. THIS INCOMPLETE CLOSURE CREATES A RISK FOR ACCIDENTAL NEEDLESTICKS. ADDITIONAL INFORMATION RECEIVED ON 24JUL2025 STATED THAT THE NURSES HAD TO DRAW ADDITIONAL EXPOSURE PROTOCOL LAB WORK FOR EACH PATIENT THAT THE NEEDLE STICK OCCURRED WITH AS THEY WERE ALL CONTAMINATED ACCIDENTAL NEEDLE STICKS (I.E. POST INJECTION WITH THE PATIENT). FIRST AID WAS APPLIED TO ALL. THERE WAS EMOTIONAL DISTRESS AND PAPERWORK FOR ALL ENCOUNTERS. ON 29JUL2025 IT WAS CONFIRMED THAT THE NURSES DID NOT REQUIRE LAB WORK OR MEDICATION.
Patient problems: Needle Stick/Puncture
MAUDE report 22743839 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.