BD Vacutainer® Eclipse™ Blood Collection Needle Pre-Attached Holder 368651Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder 22G 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 has a pre-attached holder. Many of the 81 reports describe the needle's shield being hard to activate or separating, and some describe packaging seals found open. The reports include 4 injuries and no deaths. Reports fell from 12 in the prior year to 4 in the latest year. 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
- 78
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 50382903686518), received between Nov 27, 2017 and Nov 10, 2025 — classified as 4 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (28 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 Activation28
- Leak/Splash10
- Break6
- Detachment of Device or Device Component6
- Product Quality Problem6
- Separation Problem4
- Detachment Of Device Component3
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Known Impact Or Consequence To Patient26
- Needle Stick/Puncture5
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Exposure to Body Fluids1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, TEN (10) UNITS EXHIBITED AN OPEN SEAL ON THE PACKAGING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513032 ↗MalfunctionAug 18, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY MECHANISM DETACHES FROM THE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22833451 ↗MalfunctionAug 11, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY MECHANISM SEPARATED FROM 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 22777175 ↗MalfunctionJul 22, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY MECHANISM DETACHED FROM 25 UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565720 ↗MalfunctionJul 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, SLEEVE LEAKAGE 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 22565123 ↗MalfunctionJul 14, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE NEEDLE DETACHED FROM THE HOLDER, 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 22496231 ↗MalfunctionMay 20, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY MECHANISM BROKE OFF OF THE NEEDLE OF THREE (3) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053977 ↗MalfunctionMay 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971924 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THERE WAS BLOOD LEAKING FROM THE NON PATIENT SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21402370 ↗InjuryDec 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD WAS DIFFICULT TO ENGAGE AND DID NOT FULLY COVER THE NEEDLE, CAUSING A NEEDLESTICK TO THE HEALTHCARE PROVIDER. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED. NEEDLESTICK OCCURRED ON THE LEFT THUMB. STAFF WENT TO PUT NEEDLE IN THE SHARPS CONTAINER AND DID NOT REALIZE THE SAFETY DID NOT ENGAGE PROPERLY. STAFF ENGAGED SAFETY AS USUAL AT THE END OF DRAW, BUT IT WAS HARDER TO PUSH DOWN. SAFETY WAS ENGAGED IMMEDIATELY AFTER USE. WASN'T A QUICK RELEASE AS USUAL. STAFF DID NOT HEAR THE SAFETY CLICK INTO PLACE AS NORMAL BUT DID NOT DOUBLE CHECK. THE SAFETY WAS DOWN, BUT DID NOT COVER THE NEEDLE PROPERLY.
Patient problems: Needle Stick/Puncture
MAUDE report 20926243 ↗MalfunctionDec 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER FOREIGN MATTER WAS FOUND ON THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924006 ↗MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE REMOVING THE IV SHIELD FROM A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THE ENTIRE HUB-COLLAR SEPARATED FROM THE DEVICE. THE DEVICE WAS DISCARDED. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748027 ↗MalfunctionNov 5, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED PRIOR TO USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE UNIT BLISTER WAS FOUND UNSEALED. THIS OCCURRED WITH EIGHT (8) DEVICES. THE UNSEALED DEVICES WERE NOT USED. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609567 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD DETACHED FROM THE DEVICE. THIS OCCURRED WITH 18 DEVICES. THERE WAS ONE CLEAN NEEDLE STICK INCIDENT REPORTED AS A RESULT OF THIS ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 20410730 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD DETACHED FROM THE DEVICE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241142 ↗MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SAFETY SHIELD IS DETACHING FROM AN UNSPECIFIED NUMBER OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES WITH PRE-ATTACHED HOLDER. THIS IS OCCURRING BOTH PRIOR TO AND DURING USE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153981 ↗MalfunctionSep 4, 2024Defective Component; Defective Component
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELDS WERE CRACKED / DETACHED FROM THE REST OF THE DEVICE. THIS WAS OBSERVED IN FIVE (5) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140740 ↗MalfunctionJun 17, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THAT THE SAFTEY SHIELD WAS BREAKING AND FALLING ON THE PATIENT LAP. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19554270 ↗MalfunctionJun 8, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE ECLIPSE SAFETY SHIELD FELL OFF THE DEVICE WHEN CLOSING IT OVER THE IV NEEDLE. THIS OCCURRED THREE TIMES. NO IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19493367 ↗MalfunctionJun 7, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE ECLIPSE SAFETY SHIELD DETACHED FROM THE DEVICE. NO IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487198 ↗MalfunctionApr 28, 2024Break; Break
IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THE NEEDLE FELL OFF THE COLLECTION DEVICE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19199293 ↗InjuryMar 29, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD FELL OFF OF ONE DEVICE RESULTING IN A NEEDLESTICK INJURY. PER CUSTOMER, THERE WAS NO POST EXPOSURE TESTING OR MEDICAL INTERVENTION PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 19006851 ↗MalfunctionJan 30, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD FELL OFF OF THE DEVICE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608934 ↗MalfunctionNov 15, 2023Premature Separation; Premature Separation
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER SAFETY SHIELD DETACHES DURING USE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18138940 ↗MalfunctionOct 13, 2023Separation Problem; Separation Problem
IT WAS REPORTED THAT DURING USE WITH THE VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THE SAFETY SHIELD WAS DETACHED. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PHLEBOTOMIST ALMOST RECEIVED NEEDLE STICK DUE TO DETACHED SAFETY SHIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17930538 ↗
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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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