BD Vacutainer® Eclipse™ Blood Collection Needle 368609Recalls & reported problems
Becton, Dickinson And Company · NEEDLE ECLIPSE 21X1.25 CE · Class 2
All models of BD Vacutainer Eclipse Blood Collection Needle (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Eclipse blood collection needle has 147 FDA adverse event reports, with no deaths and 4 injuries. Most describe blood leaking from the needle sleeve or hub during collection, and some mention pain. Reports jumped to 108 in the latest 12 months from 12 in the 12 months before. 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
- 149
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 30382903686095), received between Nov 27, 2017 and Sep 29, 2026 — classified as 4 injuries, 145 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (75 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
- Fluid/Blood Leak75
- Leak/Splash33
- Product Quality Problem11
- Device Contamination with Chemical or Other Material7
- Detachment of Device or Device Component6
- Difficult or Delayed Activation4
- Break3
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions134
- Exposure to Body Fluids5
- Needle Stick/Puncture4
- No Known Impact Or Consequence To Patient3
- Pain2
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937960 ↗MalfunctionSep 29, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937956 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721208 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692452 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
It was reported that when using the BD Vacutainer® Eclipse¿ Blood Collection Needle, one (1) unit exhibited hub/collar separation. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525203 ↗MalfunctionJul 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060183 ↗MalfunctionMay 18, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, AN UNSPECIFIED NUMBER OF DEVICES LEAKED BLOOD FROM NP SLEEVE. PAIN WAS ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: Pain
MAUDE report 25203079 ↗MalfunctionMay 15, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 8 DEVICES LEAKED BLOOD FROM THE NP NEEDLE DURING BLOOD COLLECTION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183891 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, AN UNSPECIFIED NUMBER OF DEVICES LEAKED BLOOD FROM THE NP NEEDLE AND CAUSED PAINFUL VENIPUNCTURE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178561 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 1 DEVICE EXHIBITED POOR SLEEVE FUNCTION AND LEAKED BLOOD FROM THE NP NEEDLE AND CAUSED PAIN TO THE PATIENT. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: Pain
MAUDE report 25174666 ↗MalfunctionMay 13, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, SLEEVE LEAKAGE OCCURRED WITH AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162114 ↗MalfunctionMay 5, 2026Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD BROKE OFF ONE (1) DEVICE WHEN ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087484 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 4 OF 15. IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035383 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 8 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035381 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 7 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035380 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 15 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035379 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 2 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035378 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 3 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035374 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 11 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035372 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 6 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035369 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 14 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035368 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 1 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE NEEDLE WAS DULL AND BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING A TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035358 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 9 OF 15. IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035353 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 5 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035351 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
REPORT 13 OF 15: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AFTER FILLING THE TUBE. THIS OCCURRED WITH ONE PATIENT AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035346 ↗
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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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