Eclipse 305895Recalls & reported problems
Becton, Dickinson And Company · NEEDLE ECLIPSE S/T 21X1-1/2 RB TW · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903058952), received between Feb 14, 2023 and Sep 18, 2026 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Difficult to Open or Close2
- Contamination1
- Defective Component1
- Detachment of Device or Device Component1
- Disconnection1
- Leak/Splash1
- Nonstandard Device1
Patient problems
- Needle Stick/Puncture5
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Nonstandard Device
The following information was provided by the initial reporter:There have been incidentsIt was reported that a customer cancelled this order and disposed of part of it due to . ¿However, Eclipse needles are being supplied, and these have been rejected within the EU due to the risk of pricking.¿They have also experienced the following: We have had incidents with these needles where colleagues, whilst securing the needle, have slipped their thumb over the pink safety guard and, as a result, ended up with their thumb inside the needle.I would like to clear this up; to my knowledge, the product simply complies with EU requirements.Could you please provide a little more clarification on this so that we can pass this information on to the customer?
Patient problems: Needle Stick/Puncture
MAUDE report 50817556 ↗MalfunctionOct 19, 2025Disconnection; Disconnection
MalfunctionFeb 10, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351540 ↗MalfunctionJan 5, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076133 ↗MalfunctionDec 12, 2024Break; Break
DURING SURGERY, THE SURGEON PASSED EMPTY SYRINGE TO THE NURSE AFTER USE. THE PLASTIC SAFETY COVER HADN¿T CLOSED PROPERLY AND HAD FAILED TO SECURE CLOSED NEEDLE STICK INJURY RESULTED AS THE NEEDS REMAINED EXPOSED AFTER INJURY A SECOND ATTEMPT TO CLOSE WAS ATTEMPTED AND THE COVER DETACHED FROM THE NEEDLE COMPLETELY WERE THERE ANY DIAGNOSTICS PERFORMED AS A RESULT OF THE CONTAMINATED NEEDLE STICK? BLOOD TESTS FOR INOCULATION INJURY POLICY. IF YES, WHAT DIAGNOSTICS WERE PERFORMED? BLOOD BORN DISEASE SCREENING. WAS ANY MEDICAL INTERVENTION REQUIRED? NO.
Patient problems: Needle Stick/Puncture
MAUDE report 20916536 ↗MalfunctionNov 27, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD DID NOT CLOSE AND THEN BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING SURGERY, THE SURGEON PASSED EMPTY SYRINGE TO THE NURSE AFTER USE. THE PLASTIC SAFETY COVER HADN'T CLOSED PROPERLY AND HAD FAILED TO SECURE CLOSED NEEDLE STICK INJURY RESULTED AS THE NEEDS REMAINED EXPOSED AFTER INJURY A SECOND ATTEMPT TO CLOSE WAS ATTEMPTED AND THE COVER DETACHED FROM THE NEEDLE COMPLETELY. 12 NOV: UNFORTUNATELY, THERE IS NO PHYSICAL SAMPLE OR PICTURE AS IT WAS A USED SHARP AND INITIALLY I DIDN'T KNOW THERE HAD BEEN A SECOND INCIDENT. THERE WAS NO PATIENT HARM ALTHOUGH SHE DID HAVE TO HAVE A SECOND BLOOD SAMPLE TAKEN. HOWEVER THERE WERE 2 MEMBERS OF STAFF THAT HAD INOCULATION INJURIES. IF YOU HAVE ANY FURTHER QUESTIONS PLEASE ASK.
Patient problems: Needle Stick/Puncture
MAUDE report 20799456 ↗MalfunctionNov 15, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close
MalfunctionJun 1, 2024Break; Break
IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1.25 CE SAFETY SHIELD BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY SHIELD BROKEN.
Patient problems: Insufficient Information; Needle Stick/Puncture
MAUDE report 19443256 ↗InjuryFeb 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE THE NEEDLE PULLED OUT OF THE HUB AND REMAINED IN THE PATIENT'S LEG. LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN HE WENT TO PUSH THE PLUNGER THE SHAFT CAME OFF THE HUB OF THE NEEDLE AND THE WAS NEEDLE LEFT IN THE LEG. THE TESTOSTERONE WAS SHOT ON THE OUTSIDE OF THE LEG. HE WENT TO THE EMERGENCY ROOM FOLLOWING THE INCIDENT WHERE THEY X-RAYED HIS LEG AND THE NEEDLE WAS STILL IN THE LEG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16376363 ↗MalfunctionFeb 14, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE 21G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WHEN YOU PUT THE BD ECLIPSE G21 NEEDLES ON THE SYRINGES, LIQUID LEAKS OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16376344 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.