BD Vacutainer® Safety-Lok™ Blood Collection Set 367283Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 30382903672838), received between Oct 27, 2017 and Apr 14, 2026 — classified as 40 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (48 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Fluid/Blood Leak; Short Fill; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED INSUFFICIENT BLOOD FLOW, SAMPLE LEAKAGE FROM A DEFECTIVE RUBBER SLEEVE, AND DIFFICULTY IN ACTIVATING THE SAFETY FEATURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879102 ↗
• InjuryFeb 9, 2026Activation Failure

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD BROKE CAUSING A NEEDLESTICK TO THE HEALTHCARE PROVIDER. NO ADVERSE IMPACT OR MEDICAL INTERVENTION WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24300078 ↗
• InjuryJan 5, 2026Product Quality Problem; Difficult or Delayed Activation

  REPORT 3 OF 4. IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE IS DIFFICULTY ACTIVATING THE SAFETY MECHANISM, CAUSING A USED NEEDLE STICK INJURY TO THE USER. REPORTED VERBATIM: "RECENTLY, A GOOD NUMBER OF NEEDLE STICK INJURIES HAVE HAPPENED WHEN AN EMPLOYEE ATTEMPTS TO INITIATE THE SAFETY MECHANISM ON THE WINGSET NEEDLE AFTER A BLOOD DRAW IS COMPLETE. A LOT OF THE TIMES, THE EMPLOYEE SAYS THAT THE MECHANISM GETS STUCK AND THEIR FINGERS SLIP, CAUSING THE NEEDLE STICK INJURY. UPDATE: THERE WERE A TOTAL OF 4 EMPLOYEES WHO SUSTAINED NEEDLE STICK INJURY AFTER USE OF BUTTERFLY. ONE WAS IN OUTPATIENT HIV CLINIC, ONE IN 4E, ONE IN 3E, AND ONE IN 6W ICU. 3 CLOSED CASES DUE TO NEGATIVE SOURCE LAB RESULTS AND THE FOURTH REMAIN OPEN UNTIL 4 MONTHS POST-EXPOSURE DUE TO +HIV SOURCE. NO EMPLOYEES REQUIRED HOSPITALIZATION."

  Patient problems: Needle Stick/Puncture

  MAUDE report 23957627 ↗
• InjuryJan 5, 2026Product Quality Problem; Difficult or Delayed Activation

  REPORT 4 OF 4. IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE IS DIFFICULTY ACTIVATING THE SAFETY MECHANISM, CAUSING A USED NEEDLE STICK INJURY TO THE USER. REPORTED VERBATIM: "RECENTLY, A GOOD NUMBER OF NEEDLE STICK INJURIES HAVE HAPPENED WHEN AN EMPLOYEE ATTEMPTS TO INITIATE THE SAFETY MECHANISM ON THE WINGSET NEEDLE AFTER A BLOOD DRAW IS COMPLETE. A LOT OF THE TIMES, THE EMPLOYEE SAYS THAT THE MECHANISM GETS STUCK AND THEIR FINGERS SLIP, CAUSING THE NEEDLE STICK INJURY. UPDATE: THERE WERE A TOTAL OF 4 EMPLOYEES WHO SUSTAINED NEEDLE STICK INJURY AFTER USE OF BUTTERFLY. ONE WAS IN OUTPATIENT HIV CLINIC, ONE IN 4E, ONE IN 3E, AND ONE IN 6W ICU. 3 CLOSED CASES DUE TO NEGATIVE SOURCE LAB RESULTS AND THE FOURTH REMAIN OPEN UNTIL 4 MONTHS POST-EXPOSURE DUE TO +HIV SOURCE. NO EMPLOYEES REQUIRED HOSPITALIZATION."

  Patient problems: Needle Stick/Puncture

  MAUDE report 23957624 ↗
• InjuryJan 5, 2026Product Quality Problem; Difficult or Delayed Activation

  REPORT 2 OF 4: IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE IS DIFFICULTY ACTIVATING THE SAFETY MECHANISM, CAUSING A USED NEEDLE STICK INJURY TO THE USER. REPORTED VERBATIM: "RECENTLY, A GOOD NUMBER OF NEEDLE STICK INJURIES HAVE HAPPENED WHEN AN EMPLOYEE ATTEMPTS TO INITIATE THE SAFETY MECHANISM ON THE WINGSET NEEDLE AFTER A BLOOD DRAW IS COMPLETE. A LOT OF THE TIMES, THE EMPLOYEE SAYS THAT THE MECHANISM GETS STUCK AND THEIR FINGERS SLIP, CAUSING THE NEEDLE STICK INJURY. UPDATE: THERE WERE A TOTAL OF 4 EMPLOYEES WHO SUSTAINED NEEDLE STICK INJURY AFTER USE OF BUTTERFLY. ONE WAS IN OUTPATIENT HIV CLINIC, ONE IN 4E, ONE IN 3E, AND ONE IN 6W ICU. 3 CLOSED CASES DUE TO NEGATIVE SOURCE LAB RESULTS AND THE FOURTH REMAIN OPEN UNTIL 4 MONTHS POST-EXPOSURE DUE TO +HIV SOURCE. NO EMPLOYEES REQUIRED HOSPITALIZATION."

  Patient problems: Needle Stick/Puncture

  MAUDE report 23957620 ↗
• MalfunctionDec 19, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE BLOOD COLLECTION SET WAS DETACHING, AND THE NON PATIENT END OF THE NEEDLE WAS BREAKING OFF OF THE HOLDER WHILE IT WAS BEING ATTACHED ON FOUR (4) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850245 ↗
• MalfunctionDec 15, 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 23809282 ↗
• InjuryDec 4, 2025Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking

  REPORT 1 OF 4. IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE IS DIFFICULTY ACTIVATING THE SAFETY MECHANISM, CAUSING A USED NEEDLE STICK INJURY TO THE USER. REPORTED VERBATIM: "RECENTLY, A GOOD NUMBER OF NEEDLE STICK INJURIES HAVE HAPPENED WHEN AN EMPLOYEE ATTEMPTS TO INITIATE THE SAFETY MECHANISM ON THE WINGSET NEEDLE AFTER A BLOOD DRAW IS COMPLETE. A LOT OF THE TIMES, THE EMPLOYEE SAYS THAT THE MECHANISM GETS STUCK AND THEIR FINGERS SLIP, CAUSING THE NEEDLE STICK INJURY. UPDATE: THERE WERE A TOTAL OF 4 EMPLOYEES WHO SUSTAINED NEEDLE STICK INJURY AFTER USE OF BUTTERFLY. ONE WAS IN OUTPATIENT HIV CLINIC, ONE IN 4E, ONE IN 3E, AND ONE IN 6W ICU. 3 CLOSED CASES DUE TO NEGATIVE SOURCE LAB RESULTS AND THE FOURTH REMAIN OPEN UNTIL 4 MONTHS POST-EXPOSURE DUE TO +HIV SOURCE. NO EMPLOYEES REQUIRED HOSPITALIZATION."

  Patient problems: Needle Stick/Puncture

  MAUDE report 23716172 ↗
• MalfunctionNov 3, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE WAS SLIPPING BACK INTO THE WINGSET UNIT WHILE ATTEMPTING TO DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450519 ↗
• MalfunctionNov 3, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE WAS SLIPPING BACK INTO THE WINGSET UNIT WHILE ATTEMPTING TO DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450455 ↗
• MalfunctionNov 3, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE WAS SLIPPING BACK INTO THE WINGSET UNIT WHILE ATTEMPTING TO DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450341 ↗
• InjuryAug 12, 2025Product Quality Problem; Difficult or Delayed Activation; Physical Resistance/Sticking; Product Quality Problem; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE STAFF OBTAINED A NEEDLESTICK INJURY DUE TO ACTIVATION DIFFICULTIES. THE STAFF WENT TO ER FOR AND WAS GIVEN PROPHYLAXIS DUE TO HIGH RISK PATIENT INVOLVED. NO OTHER INFORMATION PROVIDED. REPORTED INFORMATION: CUSTOMER STATES THE DESIGN OF THE PRODUCT CONCERNS THEM. CUSTOMER STATES THAT ACTIVATING THE SAFETY MECHANISM REQUIRES THE USER TO PULL THE TUBING BACK TO RETRACT THE NEEDLE. HOWEVER, THE TUBING DOES NOT RETRACT SMOOTHLY, AND STAFF OFTEN NEED TO APPLY EXTRA FORCE. THIS CAN CAUSE THE BUTTERFLY NEEDLE TO MOVE UNPREDICTABLY, LEADING TO ACCIDENTAL INJURY. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES, NEEDLESTICK. IF YES, DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: ALL STAFF WENT TO ER FOR NEEDLESTICK RELATED BLOODWORK BUT MOST REQUIRED NO TREATMENT BESIDES ALCOHOL PAD, GAUZE AND TAPE. ONE STAFF WAS GIVEN PROPHYLAXIS DUE TO PATIENT COLLECTED WAS CONSIDERED HIGH RISK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22785986 ↗
• InjuryAug 12, 2025Product Quality Problem; Difficult or Delayed Activation; Physical Resistance/Sticking; Product Quality Problem; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE STAFF OBTAINED A NEEDLESTICK INJURY DUE TO ACTIVATION DIFFICULTIES. THE STAFF WENT TO ER FOR AND NEEDLESTICK RELATED BLOODWORK WAS PERFORMED BUT NO TREATMENT BESIDES FIRST AID WAS GIVEN. NO OTHER INFORMATION PROVIDED. REPORTED INFORMATION: CUSTOMER STATES THE DESIGN OF THE PRODUCT CONCERNS THEM. CUSTOMER STATES THAT ACTIVATING THE SAFETY MECHANISM REQUIRES THE USER TO PULL THE TUBING BACK TO RETRACT THE NEEDLE. HOWEVER, THE TUBING DOES NOT RETRACT SMOOTHLY, AND STAFF OFTEN NEED TO APPLY EXTRA FORCE. THIS CAN CAUSE THE BUTTERFLY NEEDLE TO MOVE UNPREDICTABLY, LEADING TO ACCIDENTAL INJURY. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES, NEEDLESTICK IF YES. DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: ALL STAFF WENT TO ER FOR NEEDLESTICK RELATED BLOODWORK BUT MOST REQUIRED NO TREATMENT BESIDES ALCOHOL PAD, GAUZE AND TAPE. ONE STAFF WAS GIVEN PROPHYLAXIS DUE TO PATIENT COLLECTED WAS CONSIDERED HIGH RISK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22785358 ↗
• MalfunctionJul 10, 2025Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE WAS NO FLASH AND THE TUBE PUSHED OFF FROM THE NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469486 ↗
• InjuryJul 1, 2025Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING FOUR BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER OBTAINED NEEDLE STICK INJURY DUE TO UNFAMILIARITY WITH THE DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22370062 ↗
• MalfunctionJun 19, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE BUTTERFLY SET WAS DEFECTIVE, CONTAINING HOLE IN THE TUBING WHICH CAUSED BLOOD TO LEAK OUT, UNABLE TO FLOW INTO THE VACUTAINER. PATIENT HAD TO BE RECOLLECTED AND THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289813 ↗
• MalfunctionMay 7, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER NOTICED THAT THE SAFETY MECHANISM DID NOT ACTIVATE IMMEDIATELY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977191 ↗
• MalfunctionMay 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE LOT NUMBER ON PRODUCT IS INCORRECT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970772 ↗
• MalfunctionApr 25, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE DEVICE SEPARATED AFTER THE COLLECTION TUBE WAS PLACED IN THE HOLDER ON UNSPECIFIED NUMBER OF TIMES. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909668 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING TWO BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE SLEEVE BROKE IN HALF, AND THE PATIENT WAS STUCK AGAIN. NO OTHER PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882667 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE TUBING AND THE VACUTAINER UNLATCHED, LEAVING THE SAFETY SHIELD LOCKED HALFWAY CAUSING THE CUSTOMER TO OBTAIN A DIRTY NEEDLESTICK INJURY ON THE RIGHT MIDDLE FINGER WHEN DISPOSING. EXPOSURE TESTING WAS PERFORMED; NO OTHER INFORMATION PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21774450 ↗
• MalfunctionApr 2, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING THE USE OF 12 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE LUER ADAPTER SEPARATED FROM THE VACUTAINER AND WAS VERY DIFFICULT TO RECONNECT TO COMPLETE THE PROCEDURE. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752247 ↗
• MalfunctionMar 13, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING TEN (10) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE LUER ADAPTER DETACHED FROM THE WINGSET, AND HAD TO REATTACHED. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597625 ↗
• MalfunctionMar 11, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED PRIOR TO USING TWELVE (12) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SETS THAT THE DEVICE ADAPTER IS DETACHED FROM THE TUBING. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580318 ↗
• MalfunctionFeb 19, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE IS EXPOSED AFTER RETRACTION. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410762 ↗