BD Vacutainer® Safety-Lok™ Blood Collection Set 367292Recalls & reported problems
Becton, Dickinson And Company · WINGSET SLBCS 23X.75 7LUER · Class 2
All models of BD Vacutainer Safety-Lok Blood Collection Set (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Safety-Lok blood collection set is used to draw blood through a needle into collection tubes. Most of the 28 reports describe blood leaking or splashing during the draw, often because the rubber sleeve around the needle performed poorly or the needle pierced it, and a few mention the sleeve not retracting, sticking, or blocking. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 30382903672920), received between Nov 27, 2017 and Sep 16, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak12
- Leak/Splash12
- Break1
- Complete Blockage1
- Difficult to Open or Close1
- Retraction Problem1
- Sticking1
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787116 ↗MalfunctionMay 20, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 5 DEVICES HAD POOR SLEEVE FUNCTION AND LEAKED BLOOD FROM THE NP CANNULA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231967 ↗MalfunctionMay 12, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 1 DEVICE EXHIBITED POOR SLEEVE FUNCTION AND LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153518 ↗MalfunctionMay 7, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE PIERCED THE RUBBER SLEEVE OF 10 DEVICES RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112694 ↗MalfunctionApr 13, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE RUBBER SLEEVE FAILED TO RETRACT, CAUSING THE CANNULA TO BECOME EXPOSED AND BLOOD TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865219 ↗MalfunctionFeb 23, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24420245 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 3 DEVICES EXHIBITED POOR SLEEVE FUNCTION WHERE THE NP NEEDLE SLEEVE LEAKED DURING BLOOD DRAW AND SPILLED ONTO NURSE'S UNIFORMS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258675 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak; Retraction Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 1 DEVICE EXHIBITED POOR SLEEVE FUNCTION RECOVERY RESULTING IN BLOOD LEAKAGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235191 ↗MalfunctionJan 30, 2026Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE 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 24222444 ↗MalfunctionJan 13, 2026Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE WAS INSUFFICIENT BLOOD FLOW THROUGH FIVE (5) UNITS USING A VARIETY OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058634 ↗MalfunctionDec 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865297 ↗MalfunctionDec 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843849 ↗MalfunctionDec 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE 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 23794305 ↗MalfunctionDec 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THIRTY (30) UNITS EXHIBITED SLEEVE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23751436 ↗MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392299 ↗MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF UNITS EXHIBITED SLEEVE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392131 ↗MalfunctionSep 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22999105 ↗MalfunctionAug 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NURSE NOTICED BLOOD WAS DRIPPING FROM THE END BECAUSE THE RUBBER COVERING THE NON-PATIENT NEEDLE DID NOT RECOVER RESULTING IN CONTAMINATION OF THE NURSE'S CLOTHES ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731480 ↗MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE RUBBER SLEEVE DID NOT RETRACT DURING COLLECTION OF AN UNSPECIFIED NUMBER OF UNITS RESULTING IN THE NEEDLE BEING EXPOSED AND BLOOD LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645418 ↗MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE RUBBER SLEEVE DID NOT RETRACT DURING COLLECTION OF TWO UNITS RESULTING IN THE NEEDLE BEING EXPOSED, BLOOD LEAKAGE, AND CONTAMINATION OF THE NURSE'S UNIFORM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645383 ↗MalfunctionJul 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NON-PATIENT RUBBER PLUG DID NOT REBOUND, CAUSING THE LOWER END OF THE DEVICE TO LEAK ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523150 ↗MalfunctionJul 7, 2025Leak/Splash; Leak/Splash
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE OCCURRED FROM THE NON-PATIENT NEEDLE WHEN THE TUBE WAS INSERTED ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414518 ↗MalfunctionJul 7, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE OCCURRED FROM THE NON-PATIENT NEEDLE WHEN THE TUBE WAS INSERTED ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414052 ↗MalfunctionMay 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE TUBE WILL BOUNCE OFF THE NEEDLE, CAUSING THE TUBE TO FALL AND DELAY THE SAMPLE PROCESSING. THE PATIENT HAD TO BE STUCK AGAIN BUT THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063374 ↗MalfunctionJul 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE WINGSET LEAKED FROM THE MIDDLE OF THE TUBING ON (1) DEVICE. BLOOD GOT ON THE ARM OF THE PATIENT, BUT NO OTHER PATIENT/USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839567 ↗
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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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