BD Vacutainer® Eclipse™ Blood Collection Needle Pre-Attached Holder 368650Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder 21G x 1 1/4 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Eclipse blood collection needle is used to draw blood. Its 478 adverse event reports often describe safety shields that are hard to activate, do not lock, or pop off, with some mentioning needle-stick injuries. There are no deaths and 32 injuries. Reports fell from 74 in the prior 12 months to 28 in the last 12. 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
- 475
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 475 adverse event reports that list this exact device (DI 50382903686501), received between Oct 18, 2017 and May 19, 2026 — classified as 32 injuries, 443 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (167 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Activation167
- Leak/Splash52
- Break43
- Detachment of Device or Device Component43
- Product Quality Problem36
- Device Contamination with Chemical or Other Material35
- Detachment Of Device Component20
- Fluid/Blood Leak20
Patient problems
- No Clinical Signs, Symptoms or Conditions256
- No Known Impact Or Consequence To Patient132
- Needle Stick/Puncture35
- No Consequences Or Impact To Patient29
- No Patient Involvement11
- Exposure to Body Fluids7
- No Information5
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 475 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, AN UNSPECIFIED NUMBER OF DEVICES HAD DEFECTIVE SAFETY MECHANISMS AND BREAKS OFF FROM THE DEVICE WHEN ACTIVATED OR IS FOUND TO BE LOOSE PRIOR TO USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222131 ↗MalfunctionApr 16, 2026Difficult or Delayed Activation
REPORT 2 OF 3: IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD DID NOT LOCK PROPERLY AFTER THE SAMPLE WAS COLLECTED. THE NUMBER OF AFFECTED TUBES WAS NOT SPECIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904057 ↗MalfunctionApr 16, 2026Difficult or Delayed Activation
REPORT 1 OF 3: IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD DID NOT LOCK PROPERLY AFTER THE SAMPLE WAS COLLECTED. THE NUMBER OF AFFECTED TUBES WAS NOT SPECIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897098 ↗MalfunctionApr 16, 2026Difficult or Delayed Activation
REPORT 3 OF 3 IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD DID NOT LOCK PROPERLY AFTER THE SAMPLE WAS COLLECTED. THE NUMBER OF AFFECTED TUBES WAS NOT SPECIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897083 ↗MalfunctionApr 9, 2026Loss of or Failure to Bond; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD DETACHED FROM ONE (1) NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834688 ↗MalfunctionMar 23, 2026Difficult or Delayed Activation; Premature Separation
REPORT 1 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PAH, THE SAFETY SHIELD DETACHED FROM THE NEEDLE WHEN ATTEMPTING SHIELD ACTIVATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671062 ↗MalfunctionMar 23, 2026Difficult or Delayed Activation; Premature Separation
REPORT 2 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PAH, THE SAFETY SHIELD DETACHED FROM THE NEEDLE WHEN ATTEMPTING SHIELD ACTIVATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670785 ↗MalfunctionMar 3, 2026Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD BROKE OFF 20 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501451 ↗MalfunctionFeb 24, 2026Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY SHIELD OF ONE DEVICE DETACHED AFTER SAMPLING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431094 ↗MalfunctionFeb 9, 2026Incomplete or Missing Packaging
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, AN UNSPECIFIED NUMBER OF DEVICES WERE MISSING A SAFETY SHIELD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298528 ↗MalfunctionJan 13, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THIRTY (30) UNITS EXHIBITED THE SAFETY MECHANISM SEPARATE FROM THE UNIT DURING ACTIVATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053716 ↗MalfunctionJan 13, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, TWENTY (20) UNITS EXHIBITED THE SAFETY MECHANISM SEPARATE FROM THE UNIT DURING ACTIVATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053709 ↗MalfunctionJan 2, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT AFTER USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM WAS OBSERVED TO BE BROKEN ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23950672 ↗MalfunctionJan 2, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM WAS BROKEN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23950405 ↗MalfunctionJan 2, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, HUB/COLLAR SEPARATION OCCURRED ON TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23949262 ↗MalfunctionJan 2, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, HUB/COLLAR SEPARATION OCCURRED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23949260 ↗MalfunctionJan 2, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, HUB/COLLAR SEPARATION OCCURRED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23949259 ↗MalfunctionDec 22, 2025Backflow; Backflow
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, BACK FLOW WAS EXPERIENCED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 23871503 ↗MalfunctionDec 22, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM BROKE ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871471 ↗MalfunctionDec 22, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, HUB/COLLAR SEPARATION OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23867562 ↗MalfunctionDec 18, 2025Difficult to Insert; Difficult or Delayed Activation; Difficult to Insert; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM SEPARATED, AND TUBE PUSH OFF FROM THE NON-PATIENT END OF THE CANNULA OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838607 ↗MalfunctionDec 18, 2025Difficult to Insert; Difficult or Delayed Activation; Difficult to Insert; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM SEPARATED, AND TUBE PUSH OFF FROM THE NON PATIENT END OF THE CANNULA OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838606 ↗MalfunctionDec 18, 2025Difficult to Insert; Difficult or Delayed Activation; Difficult to Insert; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER, THE SAFETY MECHANISM SEPARATED, AND TUBE PUSH OFF FROM THE NON-PATIENT END OF THE CANNULA OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838275 ↗MalfunctionNov 13, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THERE WAS HUB/COLLAR SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547110 ↗MalfunctionNov 13, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THERE WAS HUB/COLLAR SEPARATION ON THREE (3) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547109 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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