Eclipse 305892Recalls & reported problems
Becton, Dickinson And Company · NEEDLE ECLIPSE S/T 23X1 RB · Class 2
Quick summary
This BD Eclipse needle is a single-lumen hypodermic needle used to draw up and give injections such as flu and hepatitis B vaccines. The 54 reports mostly describe the needle hub or attachment coming loose, popping off the syringe, leaking fluid, blocking, or breaking during use, often forcing doses to be discarded; no deaths and no injuries were reported. There are no recalls naming this device. Reports doubled from 10 in the earlier 12 months to 20 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00382903058921), received between Nov 12, 2018 and Sep 25, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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
- Leak/Splash21
- Connection Problem18
- Complete Blockage13
- Break10
- Disconnection3
- Activation Problem2
- Contamination1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Insufficient Information14
- No Known Impact Or Consequence To Patient3
- Pain3
- Needle Stick/Puncture2
- Anxiety1
- Discomfort1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Activation Problem
The following information was provided by the initial reporter:It was reported that, during activation of the safety mechanism, the needle tip failed to engage fully into the protective shield. Only the proximal part of the safety mechanism locked into place, leaving the needle partially exposed and resulting in a needlestick injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896553 ↗MalfunctionSep 11, 2026Activation Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50739936 ↗MalfunctionApr 20, 2026Leak/Splash
IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE S/T 23X1 RB HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿ IT WAS REPORTED THAT DISCARDED 3 TRIAXIS VACCINES WITH BATCH NUMBER: X3C40D1 WHEN THE ATTACHMENT CAME LOOSE WHEN THE NEEDLE WAS SCREWED INTO PLACE. THE EXACT SAME THING HAPPENED WITH ALL THREE VACCINES. IT WAS POSSIBLE TO REATTACH THE ATTACHMENT TO THE VACCINE, BUT IT CAME LOOSE EVERY TIME THE NEEDLE WAS SCREWED IN, SO IT COULD ALSO BE DUE TO THE NEEDLES. IT FELT LIKE THERE WAS "AIR PRESSURE" IN THE SYRINGE THAT PUSHED UP BOTH THE ATTACHMENT AND THE NEEDLE. LOT NUMBER ON THE NEEDLES: 2501003. THEN, DURING MONDAY'S VACCINATION A BLUNT NEEDLE WAS DISCOVERED, WHICH ALSO HAD TO BE DISCARDED, WITH THE SAME LOT NUMBER INJECTING THE VACCINE INTO THE LEFT ARM, I NOTICE THAT THE DOSE ENDS UP TO THE SIDE, DROPS ON THE ARM. RAN WHERE THE NEEDLE IS SCREWED IN. UNCLEAR HOW MUCH OF THE DOSE WENT IN. DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932224 ↗MalfunctionApr 3, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783124 ↗MalfunctionMar 19, 2026Connection Problem
IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE S/T 23X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ATTACHING TO THE GLASS CONE IS DIFFICULT AND CAUSES THE ATTACHED LUER LOCK CONE TO POP OFF THE GLASS SYRINGE THE SAMPLES ARE ATTACHED. WHEN DID THE INCIDENT OCCUR? DURING USE. SHORT DESCRIPTION ON THE GLASS SYRINGE OF THE VACCINES, THE LUER LOCK HUB FITTED BY THE SYRINGE MANUFACTURER COMES LOOSE WHEN THE SYRINGE IS SCREWED ON. ADDITIONAL INFORMATION PROVIDED: WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? DURING AND AFTER USE WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO ONE WOULD BE HARMED COULD YOU PLEASE CONFIRM WHETHER THE SAMPLE IS READY FOR COLLECTION? THE SAMPLES ARE BEING SENT TO HEIDELBERG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24642826 ↗MalfunctionMar 2, 2026Leak/Splash; Connection Problem
THIS MDR IS THE RESULT OF ADDITIONAL INFORMATION AND SAMPLE RECEIVED FROM THE CUSTOMER. BASED ON THE FOLLOW UP RESPONSE IT WAS REPORTED THAT "I HEREBY CONFIRM THAT BETWEEN (B)(6) AND (B)(6) 2025 PROBLEMS OCCURRED WITH THE CANNULAS." ORIGINAL REPORT: IT WAS REPORTED THAT "IT IS WITH GREAT FRUSTRATION THAT I HAVE TO INFORM YOU THAT IN OUR TEAM OF 20 DOCTORS WE HAVE NOW HAD TO DISCARD SEVERAL VACCINES; AT LEAST 6 INFLUENZA VACCINES AND 3 HEPATITIS B VACCINES - BECAUSE THE BD CANNULAS DID NOT CONNECT CORRECTLY WITH THE VACCINATION SYRINGES. THE VACCINE LEAKED SIDEWAYS AND THEREFORE HAD TO BE DISPOSED OF!" WE WOULD LIKE TO ASK YOU TO COVER THE COSTS OF THE AFFECTED VACCINES AND TO INFORM US WHICH LOTS, IN ADDITION TO THE ONE SHOWN IN THE ATTACHED PICTURE, ARE ALSO AFFECTED AND MUST BE DISCARDED. WHEN DID THE INCIDENT OCCUR? BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483356 ↗MalfunctionFeb 26, 2026Leak/Splash; Connection Problem
IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE S/T 23X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT, DIFFICULT TO INSERT THREADS AT AN ANGLE, LEAKAGE ADDITIONAL INFORMATION PROVIDED: NO - PATIENT/ USER WAS NOT HARMED. DATE OF EVENT: 2026-02-19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457459 ↗MalfunctionFeb 17, 2026Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373055 ↗MalfunctionFeb 17, 2026Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373054 ↗MalfunctionFeb 6, 2026Leak/Splash; Connection Problem
MalfunctionJan 7, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995161 ↗MalfunctionJan 4, 2026Leak/Splash; Connection Problem
CANNULA CANNOT BE FIRMLY ATTACHED TO INJECTION SYRINGES WITH LL - DRIPS AND TURNS OVER WHEN TIGHTENED MORE FIRMLY. ON (B)(6) 2025: THE FACT THAT OTHER CANNULAS FROM OTHER LOTS ARE ALSO RELATIVELY EASY TO OVERTIGHTEN IS A CUSTOMER FEEDBACK. THESE CUSTOMERS VACCINATE BETWEEN APPROXIMATELY 30 AND 80 PEOPLE DAILY. THEY HAVE BEEN DOING THIS FOR MANY YEARS AND HAVE NEVER HAD ANY PROBLEMS WITH OVERTIGHTENING. NOW THEY ARE USING OUR BD ECLIPSE AND ARE EXPERIENCING PROBLEMS. THIS IS BASED ON GENERAL FEEDBACK. THERE IS NO INFORMATION AVAILABLE REGARDING OTHER LOTS. NO (WAS PATIENT OR A USER HARMED?).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23953878 ↗MalfunctionJan 4, 2026Leak/Splash; Connection Problem
WHEN WRITING THE CANNULA ONTO THE SYRINGE WITH LUER-LOCK, THE CANNULA TURNS SLIGHTLY OVER. A FIRM CONNECTION CANNOT BE MADE. LEAKAGE OCCURS DURING THE APPLICATION OF THE VACCINES. CAN ALSO BE OVER-TWISTED RELATIVELY QUICKLY WHEN THEY ARE CONNECTED TO THE SYRINGES. ON (B)(6). THE FACT THAT OTHER CANNULAS FROM OTHER LOTS ARE ALSO RELATIVELY EASY TO OVERTIGHTEN IS A CUSTOMER FEEDBACK. THESE CUSTOMERS VACCINATE BETWEEN APPROXIMATELY 30 AND 80 PEOPLE DAILY. THEY HAVE BEEN DOING THIS FOR MANY YEARS AND HAVE NEVER HAD ANY PROBLEMS WITH OVERTIGHTENING. NOW THEY ARE USING OUR BD ECLIPSE AND ARE EXPERIENCING PROBLEMS. THIS IS BASED ON GENERAL FEEDBACK. THERE IS NO INFORMATION AVAILABLE REGARDING OTHER LOTS. NO (WAS PATIENT OR A USER HARMED?).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23953877 ↗MalfunctionDec 27, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901559 ↗MalfunctionDec 27, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
WHEN THE ATTACHMENT CAME LOOSE WHEN THE NEEDLE WAS SCREWED INTO PLACE. THE EXACT SAME THING HAPPENED WITH ALL THREE VACCINES. IT WAS POSSIBLE TO REATTACH THE ATTACHMENT TO THE VACCINE, BUT IT CAME LOOSE EVERY TIME THE NEEDLE WAS SCREWED IN, SO IT COULD ALSO BE DUE TO THE NEEDLES. IT FELT LIKE THERE WAS "AIR PRESSURE" IN THE SYRINGE THAT PUSHED UP BOTH THE ATTACHMENT AND THE NEEDLE. INJECTING THE VACCINE INTO THE LEFT ARM, I NOTICE THAT THE DOSE ENDS UP TO THE SIDE, DROPS ON THE ARM. RAN WHERE THE NEEDLE IS SCREWED IN. UNCLEAR HOW MUCH OF THE DOSE WENT IN. RESPONSE RECEIVED ON:12/15/2025 1:59 PM COULD YOU PLEASE CONFIRM THE PATIENT IMPACT? CREATED DISCOMFORT FOR THE STUDENT WHO WAS TO BE VACCINATED WHERE THE NEEDLE WAS BLUNT (THE STUDENT WAS ALSO AFRAID OF INJECTIONS) AND HAD TO STOP TO PREPARE A NEW DOSE. NEW SITUATION (12/12) - WHERE PART OF THE DOSE RAN NEXT TO THE PUPIL MEANS A NEW VACCINATION.
Patient problems: Discomfort
MAUDE report 23901558 ↗MalfunctionDec 16, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23819198 ↗MalfunctionDec 15, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804401 ↗MalfunctionDec 12, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796421 ↗MalfunctionDec 12, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
MalfunctionDec 10, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773927 ↗MalfunctionNov 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466436 ↗MalfunctionNov 3, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23451786 ↗MalfunctionAug 1, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689579 ↗MalfunctionJun 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEEDLE ECLIPSE LEAKED AT CONNECTION WITH SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025 VACCINE/LIQUID HAS LEAKED ON ADMINISTRATION OF MENQUADFI VACCINATION, NEEDLE DID NOT BECOME DETACHED. PARENT HAS BEEN CONTACTED AND VACCINATION WILL NEED TO BE REPEATED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330929 ↗MalfunctionJun 24, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
IT WAS REPORTED THAT BD NEEDLE ECLIPSE DIFFICULT/POOR CONNECTION WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFICULT TO ATTACH TO WHEN DID THE INCIDENT OCCUR - DURING USE CUSTOMER EXPLAINS: "THE NEEDLES WE ORDERED FROM YOU, CALLED BD ECLIPSE NEEDLE 23 G (0.6 MM X 25 MM), ARE DIFFICULT TO ATTACH TO, FOR EXAMPLE, GARDASIL9. THESE NEEDLES HAVE LIKELY CAUSED VACCINE LEAKAGE DURING THE LUER LOCK CONNECTION". FOLLOW-UP RESPONSE RECEIVED ON 10-JUN-2025: WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? YES WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN - NO WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? YES IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED. THE NEEDLE DOES NOT FIT THE SYRINGE, LEAKAGE OCCURRED AS IT DOES NOT SEAL PROPERLY WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323037 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.