BD Vacutainer® Safety-Lok™ Blood Collection Set 367281Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 30382903672814), received between Nov 27, 2017 and Sep 11, 2026 — classified as 29 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (24 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734676 ↗
• MalfunctionMar 30, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF TUBES WOULD NOT FILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24733885 ↗
• MalfunctionMar 12, 2026Material Separation

  REPORT 6 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579906 ↗
• MalfunctionMar 11, 2026Material Separation

  REPORT 5 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576609 ↗
• MalfunctionMar 11, 2026Material Separation

  REPORT 4 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572538 ↗
• MalfunctionMar 11, 2026Material Separation

  REPORT 3 OF 6. IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572536 ↗
• MalfunctionMar 11, 2026Material Separation

  REPORT 1 OF 6. IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572534 ↗
• MalfunctionMar 11, 2026Material Separation

  REPORT 2 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572532 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, A DIRTY NEEDLESTICK HAPPENED TO THE HEALTHCARE PROVIDER. THE HEALTHCARE PROVIDER WASHED THOROUGHLY AND RECEIVED PROPER EXPOSURE MANAGEMENT IN THE EMERGENCY DEPARTMENT. CONTINUED MONITORING WAS CONDUCTED PER THEIR COMPANY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314944 ↗
• 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 22787111 ↗
• 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 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 22786958 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED ON FOUR (4) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639343 ↗
• MalfunctionMay 7, 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 21977190 ↗
• MalfunctionMay 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE 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 21977179 ↗
• InjuryApr 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THERE WAS A HIGHER INCIDENCE OF NEEDLE PUNCTURES WITH SAFETY-LOK NEEDLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORTED VERBATIM, "WE¿VE HAD HIGHER INCIDENCE OF NEEDLE PUNCTURES WITH SAFETY-LOK NEEDLES. -WAS THERE MEDICAL INTERVENTION? NO - WAS THERE A NEEDLE/PROBE STICK? YES"

  Patient problems: Needle Stick/Puncture

  MAUDE report 21868596 ↗
• MalfunctionMar 26, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER EXPERIENCED DIFFICULTY ENGAGING THE SAFETY SHIELD.. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698665 ↗
• InjuryMar 18, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER STATES THE NEEDLE DID NOT RETRACT RESULTING IN NEEDLESTICK INJURY ON THE RIGHT THUMB. THE NURSE WAS SENT TO ER FOR BASELINE TESTING, VACCINES (IF NEEDED) AND PLACED ON ANTI-VIRAL MEDICATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21632612 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE STAFF NOTICED BLOOD LEAKING AROUND THE TUBE AND NOT GOING INSIDE THE TUBE. UPON EXAMINATION, IT WAS DISCOVERED THAT THE NON-PATIENT NEEDLE WAS BENT AND UNABLE TO BE FIXED. THE DEFECTIVE NEEDLE WAS REMOVED AND THEN A SYRINGE WAS SCREWED INTO THE BLOOD COLLECTION SET TUBING AND BLOOD DRAW WAS SUCCESSFUL WITHOUT HARM TO THE PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641153 ↗
• MalfunctionOct 15, 2024Difficult to Insert; Separation Problem; Difficult to Insert; Separation Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE WAS DULL, THE TUBES PUSH OFF NON-PATIENT NEEDLE AND THE RUBBER DOES NOT CLOSE BACK OVER NON-PATIENT NEEDLE AFTER TUBE WITHDRAWAL ON THREE (3) DEVICES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453211 ↗
• MalfunctionJun 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE RUBBER SHEATH ON LUER WAS NOT COVERING THE NON-PATIENT NEEDLE, SO WHEN THE TUBE WAS REMOVED, BLOOD LEAKED FROM THE LUER ON (1) DEVICE. BLOOD EXPOSURE ON CLOTHING AND PATIENT SKIN WAS REPORTED, AND NO OTHER PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493899 ↗
• MalfunctionJun 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, CUSTOMER STATES THE RUBBER SHEATH ON THE LUER WAS NOT COVERING THE NON-PATIENT NEEDLE, AND WHEN THE TUBE WAS REMOVED; IT CAUSED BLOOK TO LEAK. THIS IS A REPORT OF ONE OCCURRENCE, AND NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481082 ↗
• MalfunctionMay 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE WAS BLOOD LEAKAGE FROM THE END WITH THE SHEATH AFTER THE TUBE WAS DETACHED. THE BLOOD DRIPPED ON THE PATIENTS ARM AND CLOTHING, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE CUSTOMER REPORTED THIS OCCURRED AT LEAST 10 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319462 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE SLEEVE LEAKAGE OCCURRED DURING COLLECTION. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991811 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT WINGSETS NOT DRAWING BLOOD CORRECTLY. BLOOD SPLATTERS EVERYWHERE ALMOST AS IF IT HAS NO TOP ON IT AT ALL. IT GOES ALL OVER THE PATIENT AND THE LAB CHAIR. THE STAFF WAS EXPOSED TO BLOOD BUT NO ADVERSE MEDICAL IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940397 ↗
• MalfunctionFeb 16, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE WINGSET DIDN'T GAIN SUCTION AND COLLECT BLOOD DURING USE. ONE QUANTITY AFFECTED. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723662 ↗