BD Vacutainer® Safety-Lok™ Blood Collection Set 367287Recalls & reported problems
Becton, Dickinson And Company · WINGSET SLBCS 21X.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 into tubes during venipuncture. Most of the 30 reports describe blood leaking or splashing from the set during the draw, along with a few cases where the needle would not retract properly or came apart from the holder; one report mentions a needlestick. There are no deaths, one injury, and 29 malfunction reports, with no recalls naming this device. Reports fell from 20 in the prior 12 months to 5 in the most recent 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 30382903672876), received between Nov 27, 2017 and Sep 10, 2026 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 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
- Leak/Splash20
- Difficult or Delayed Activation4
- Fluid/Blood Leak4
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Material Deformation1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Needle Stick/Puncture1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Retraction Problem
It was reported while using BD Vacutainer® Safety-Lok¿ Blood Collection Set, the rubber stopper at the end of three devices did not spring back, resulting in blood leakage. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721207 ↗MalfunctionMay 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKED FROM THE RUBBER SLEEVE OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302616 ↗MalfunctionMar 3, 2026Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES HAD A RETRACTION DIFFICULTY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503558 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE SEPARATED FROM THE HOLDER IN ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483777 ↗MalfunctionDec 1, 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 23682655 ↗MalfunctionNov 4, 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 23464470 ↗MalfunctionOct 27, 2025Leak/Splash; Leak/Splash
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 23390484 ↗MalfunctionOct 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SLEEVE FAILED TO RESEAL PROPERLY, RESULTING IN SLEEVE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336854 ↗MalfunctionSep 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956149 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916510 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING 3 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773168 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING TWO BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772462 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING 3 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771254 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE 7 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKS FROM THE NON-PATIENT NEEDLE DUE TO THE RUBBER SLEEVE NOT REBOUNDING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770256 ↗MalfunctionAug 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKED FROM NEEDLE AND THE NON-PATIENT SLEEVE DID NOT REBOUND. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22741416 ↗MalfunctionAug 7, 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 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 22737643 ↗MalfunctionAug 7, 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 RESULTING IN CONTAMINATION OF THE NURSE'S MEDICAL GLOVES ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737640 ↗MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE WAS OBSERVED WITH 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 22644524 ↗MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE WAS OBSERVED WITH ONE UNIT RESULTING IN CONTAMINATION OF THE NURSE'S GLOVES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644490 ↗MalfunctionJul 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE WAS OBSERVED ON TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22636158 ↗MalfunctionJul 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKED FROM THE TIP OF THE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630398 ↗MalfunctionJul 23, 2025Leak/Splash; Leak/Splash
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE OCCURRED AT THE END OF NON-PATIENT NEEDLE CAUSING CONTAMINATION ON THE BED SHEETS, PATIENTS' CLOTHES AND NURSES' CLOTHES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576008 ↗MalfunctionJul 23, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 2 IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKAGE OCCURRED AT THE END OF NON-PATIENT NEEDLE ON UNSPECIFIED NUMBER OF TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574711 ↗MalfunctionJun 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING TEN (10) UNSPECIFIED BD VACUTAINER® TUBE, THE CUSTOMER NOTICED BLOOD LEAKAGE AT THE END OF THE BLOOD COLLECTION TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342008 ↗MalfunctionMar 14, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BEFORE USING FOUR (4) BOXES OF BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER NOTICED WRONG LABEL OF EXPIRY DATE ON BOXES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21610180 ↗
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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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