BD Vacutainer® Eclipse™ Blood Collection Needle 368607Recalls & reported problems
Becton, Dickinson And Company · Becton Dickinson and Company, USA 21G x 1 1/4 · 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 1,205 adverse event reports, with no deaths and 125 injuries. Many reports describe the safety shield being slow or hard to activate, and others describe blood leaking, needles breaking, or shields coming loose. Some reports mention needle sticks. No recalls name this device. Reports in the last 12 months (174) are more than in the 12 months before (119).
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
- 1,220
- Deaths reported
- 0
- Injuries reported
- 126
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,220 adverse event reports that list this exact device (DI 30382903686071), received between Oct 25, 2017 and Sep 28, 2026 — classified as 126 injuries, 1,094 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (339 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
- Difficult or Delayed Activation339
- Leak/Splash228
- Product Quality Problem143
- Device Contamination with Chemical or Other Material93
- Break91
- Fluid/Blood Leak73
- Separation Problem51
- Detachment Of Device Component46
Patient problems
- No Clinical Signs, Symptoms or Conditions630
- No Known Impact Or Consequence To Patient328
- Needle Stick/Puncture115
- No Consequences Or Impact To Patient83
- No Patient Involvement38
- Exposure to Body Fluids20
- No Information7
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 1,220 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926544 ↗MalfunctionSep 28, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923628 ↗MalfunctionSep 28, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923621 ↗MalfunctionSep 28, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923620 ↗MalfunctionSep 28, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923607 ↗InjurySep 24, 2026Difficult or Delayed Activation; No Apparent Adverse Event
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50892036 ↗MalfunctionSep 24, 2026Difficult or Delayed Activation
Report 2 of 2It was reported when activating the safety shield of the BD Vacutainer® Eclipse¿ Blood Collection Needle, the safety shield does not cover the needle and/or breaks off. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884819 ↗MalfunctionSep 23, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870508 ↗MalfunctionSep 22, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862365 ↗MalfunctionSep 22, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862363 ↗MalfunctionSep 22, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857566 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846037 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830958 ↗MalfunctionSep 15, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780211 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763164 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that when using the BD Vacutainer® Eclipse¿ Blood Collection Needle, one (1) unit exhibited sleeve leakage, requiring recollection of the sample. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755333 ↗MalfunctionSep 10, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722249 ↗MalfunctionSep 10, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722240 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698868 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523157 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166659 ↗MalfunctionMay 28, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM 120 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318551 ↗MalfunctionMay 28, 2026Fluid/Blood Leak
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM 85 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318549 ↗MalfunctionMay 28, 2026Fluid/Blood Leak
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM 73 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318280 ↗MalfunctionMay 27, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE EIGHT (8) TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309542 ↗
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units 367962Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall693 reports
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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