BD Luer-Lok, BD Eclipse 305782Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB · Class 2
All models of BD Luer-Lok, BD Eclipse (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Luer-Lok syringe with a detachable needle is used for injections and blood draws. The 47 reports mostly describe leaking or splashing at the Luer connection, contamination or staining found inside the package, and inaccurate volume readings, along with a few parts separating or deforming. No deaths or injuries were reported, and no recalls name this device.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00382903057825), received between Nov 6, 2017 and Oct 15, 2025 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash12
- Device Contamination with Chemical or Other Material11
- Volume Accuracy Problem10
- Defective Component4
- Device Markings/Labelling Problem2
- Material Deformation2
- Material Protrusion/Extrusion2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Known Impact Or Consequence To Patient10
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
WHEN USED FOR BLOOD DRAWING THE SYRINGE STOPPER IS DEFORMED, CAUSING THE SAMPLE TO LEAK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300364 ↗MalfunctionJul 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB LEAKED AT LUER CONNECTION IT WAS REPORTED BY CUSTOMER THAT BD ECLIPSE 3ML 23G X 1IN LEAKS WHEN LUER-LOK ATTACHED TO IV CATHETER. RCC RECEIVED A COMPLAINT VIA EMAIL. BD ECLIPSE 3ML 23G X 1IN LEAKS WHEN LUER-LOK ATTACHED TO IV CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384632 ↗MalfunctionMay 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305782 , BATCH # 4187641. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER, AND INCLUDE COMPLAINT# (B)(4) ON ANY FUTURE COMMUNICATIONS. INJURIES OR ADVERSE EVENT: NO. ITEM: 305782. QUANTITY AFFECTED:1CS. SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE ITEM IS LEAKING WHEN ATTACHED TO AN EXTENSION SET; LEAKING WHERE LUER CONNECTOR MEETS THE SET. THIS IS HAPPENING ON ONLY THIS SYRINGE AND ISSUE DOES NOT OCCUR WHEN USING A DIFFERENT PRODUCT FROM BD. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22075200 ↗MalfunctionSep 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MalfunctionJul 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD ECLIPSE¿ SYRINGE HAD A STAIN ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THERE IS STAIN ON THE NEEDLE WHEN OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17335264 ↗MalfunctionJul 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD ECLIPSE¿ SYRINGE HAD A STAIN IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THERE IS STAIN IN THE BARREL WITHOUT OPEN THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17334456 ↗MalfunctionFeb 1, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16281011 ↗MalfunctionJan 28, 2023Material Separation; Material Separation
IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE THE STOPPER SEPARATED FROM THE PLUNGER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCONNECT BETWEEN PLUNGER AND STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261158 ↗MalfunctionJan 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE¿S A UNDETERMINED SUBSTANCE FOUND IN THE SYRINGE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16164993 ↗MalfunctionAug 29, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A BROKEN BARREL.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15316896 ↗MalfunctionAug 10, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE LEAKED DURING USE ONCE LOCKED IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE HAD MULTIPLE ISSUES WITH THE 3ML ECLIPSE BD LUER-LOK LEAKING WHEN THEY ARE LOCKED IN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15205489 ↗MalfunctionMar 23, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE STOPPER WAS MISALIGNED IN THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869885 ↗MalfunctionMar 20, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE WAS MISSING ITS SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCALE MISSING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13828979 ↗MalfunctionJan 27, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13374013 ↗MalfunctionJan 24, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE A DEFECT IN SCALE MARKING WAS DISCOVERED IN 129 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCALE SKEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13338485 ↗MalfunctionJan 19, 2022Defective Component; Defective Component
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD A DAMAGED COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN ADAPTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13297061 ↗MalfunctionJan 19, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT THE STOPPER WAS DISTORTED AND THE SCALE MARKINGS WERE MISALIGNED ON THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THIS EVENT OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER, SYRINGE SCALE IS SKEWED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13294361 ↗MalfunctionJan 19, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES ON THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THIS EVENT OCCURRED 56 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE SCALE IS SKEWED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13290932 ↗MalfunctionJan 19, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE SCALE IS SKEWED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13290169 ↗MalfunctionJan 18, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE HAD SCALE MARKINGS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SCALE IS SKEWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286414 ↗MalfunctionJan 18, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED WHILE USING SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB THE SCALE MARKINGS WERE IMPRECISE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SCALE IS SKEWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13283276 ↗MalfunctionDec 17, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD ECLIPSE¿ NEEDLE, THE DEVICE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: STOPPER LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025086 ↗MalfunctionDec 8, 2021Leak/Splash; Volume Accuracy Problem; Leak/Splash; Volume Accuracy Problem
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE HAD SLANTED SCALE MARKINGS AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE& WERE OBSERVED WITH SLANT SCALE MARKING ON THE SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12964550 ↗MalfunctionDec 8, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN ADAPTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12964477 ↗MalfunctionNov 24, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT 10 BD LUER-LOK¿ SYRINGES WITH DETACHABLE BD ECLIPSE¿ NEEDLE HAD MISALIGNED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE IS TOO SLIPPERY TO APPLY FORCE WHEN OPERATING WITH GLOVES". VIA BD INVESTIGATION: "FROM THE SAMPLE, THE TEAM OBSERVED POOR ASSEMBLY BETWEEN THE STOPPER AND THE PLUNGER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870798 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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