BD Luer-Lok, BD Eclipse 305784Recalls & reported problems
Becton, Dickinson And Company · SYR 3ML LL W/NDL ECLIPSE 21X1-1/2 RB TW · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903057849), received between Apr 17, 2018 and Oct 3, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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
- Leak/Splash2
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 SYR 3ML LL W/NDL ECLIPSE 21X1-1/2 RB TW FROM LOT# 8327538, AND 1 SYRINGE FROM LOT# 8302609 LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CMT: LEAKS".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9151577 ↗MalfunctionJun 12, 2018Leak/Splash
IT WAS REPORTED THAT THE AFTER DRAWING UP MEDICATION USING THE BD ECLIPSE¿ NEEDLES - BD LUER-LOK¿ SYRINGE, A LEAKAGE OCCURRED AT THE THREADED JUNCTION POINT. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7591338 ↗MalfunctionApr 17, 2018Fluid/Blood Leak
IT WAS REPORTED THAT WHILE USING A BD ECLIPSE¿ SAFETY NEEDLE WITH BD LUER-LOKTM SYRINGE, IT LEAKED BETWEEN THE THREAD OF THE SYRINGE AND THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Information
MAUDE report 7436944 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.