BD Vacutainer® Safety-Lok™ Blood Collection Set 367285Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30382903672852), received between Dec 6, 2017 and May 28, 2025 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE FELL OFF FROM THE PATIENT'S ARM ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096351 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE OFF IN PATIENT'S ARM WHEN CUSTOMER TRIED TO USE IT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853045 ↗
• MalfunctionJun 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE LUER ADAPTER DISCONNECTED CAUSING BLOOD TO LEAK. THIS EVENT OCCURRED 1 TIME AND NO PATIENT OR USER IMPACT REPORTED AS BLOOD EXPOSURE WAS ONLY ON THE GLOVES AND THE PATIENT CHAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632656 ↗
• InjuryApr 3, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD IS HARD TO ACTIVATE AND CAUSED A NEEDLESTICK INJURY TO THE HEALTH CARE WORKER. POST EXPOSURE PROTOCOL WAS FOLLOWED. FURTHER INFORMATION ABOUT DETAILED MEDICAL CARE WAS NOT PROVIDED. NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19037932 ↗
• InjuryApr 3, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD IS HARD TO ACTIVATE AND CAUSED A NEEDLESTICK INJURY TO THE HEALTH CARE WORKER. POST EXPOSURE PROTOCOL WAS FOLLOWED. FURTHER INFORMATION ABOUT DETAILED MEDICAL CARE WAS NOT PROVIDED. NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19037893 ↗
• InjuryApr 3, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD IS HARD TO ACTIVATE AND CAUSED A NEEDLESTICK INJURY TO THE HEALTH CARE WORKER. POST EXPOSURE PROTOCOL WAS FOLLOWED. FURTHER INFORMATION ABOUT DETAILED MEDICAL CARE WAS NOT PROVIDED. NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19037786 ↗
• InjuryApr 3, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD IS HARD TO ACTIVATE AND CAUSED A NEEDLESTICK INJURY TO THE HEALTH CARE WORKER. POST EXPOSURE PROTOCOL WAS FOLLOWED. FURTHER INFORMATION ABOUT DETAILED MEDICAL CARE WAS NOT PROVIDED. NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19037778 ↗
• InjuryMar 25, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE SAFETY SHIELD IS HARD TO ACTIVATE CAUSING 4 NEEDLESTICKS. EACH AFFECTED NURSE HAD TO HAVE HIC, HEP C AND HEP B TESTS PERFORMED. AT LEAST 2 STAFF HAD TO HAVE FURTHER MEDICAL INTERVENTION. REPORT 4 OF 4.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18970089 ↗
• InjuryMar 25, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE SAFETY SHIELD IS HARD TO ACTIVATE CAUSING 4 NEEDLESTICKS. EACH AFFECTED NURSE HAD TO HAVE HIV, HEP C AND HEP B TESTS PERFORMED. AT LEAST 2 STAFF HAD TO HAVE FURTHER MEDICAL INTERVENTION. REPORT 2 OF 4.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18970088 ↗
• InjuryMar 25, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE SAFETY SHIELD IS HARD TO ACTIVATE CAUSING 4 NEEDLESTICKS. EACH AFFECTED NURSE HAD TO HAVE HIC, HEP C AND HEP B TESTS PERFORMED. AT LEAST 2 STAFF HAD TO HAVE FURTHER MEDICAL INTERVENTION. REPORT 3 OF 4.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18970087 ↗
• InjuryMar 25, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE SAFETY SHIELD IS HARD TO ACTIVATE CAUSING 4 NEEDLESTICKS. EACH AFFECTED NURSE HAD TO HAVE HIC, HEP C AND HEP B TESTS PERFORMED. AT LEAST 2 STAFF HAD TO HAVE FURTHER MEDICAL INTERVENTION. REPORT 1 OF 4.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18969928 ↗
• MalfunctionApr 11, 2023Short Fill; Air/Gas in Device; Short Fill; Air/Gas in Device

  IT WAS REPORTED, THAT DURING USE WITH BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET. AIR BUBBLES FORM IN THE TUBE THUS PREVENTING RESULTING IN A LOW FILL. PATIENT HAD TO BE RE-DRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BUTTERFLY NEEDLE WITH AIR BUBBLES APPEARING IN THE TUBE BEFORE BLOOD GETS TO THE HUB, OR DURING THE TRANSFER WITHOUT THE NEEDLE LEAVING THE VEIN. THE AIR BUBBLE INTERRUPTS THE FLOW TO WHERE IT STOPS IN GENERAL, OR NOT MUCH MORE BLOOD CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714767 ↗
• MalfunctionFeb 14, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THERE WAS A SHIELD ACTIVATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE COLLECTION DEVICE DOES NOT HAVE SAFETY LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372833 ↗
• MalfunctionMar 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THERE WAS BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE NEEDLE WAS INSERTED INTO THE CHILD'S BLOOD VESSEL, BLOOD BURST FROM THE NEEDLE SEAM AND POURED OUT OF THE HAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765551 ↗
• MalfunctionOct 17, 2019Leak/Splash; Volume Accuracy Problem; Leak/Splash; Volume Accuracy Problem

  IT WAS REPORTED THAT TUBING SEPARATED FROM THE BARREL AND THERE WAS INSUFFICIENT BLOOD FLOW WITH A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET. THE TUBES HAVING INSUFFICIENT BLOOD FLOW OCCURRED ON 5 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WOULD LIKE TO REPORT INSUFFICIENT BLOOD FLOW WITNESSED WHEN USING PRODUCT 367285. FACILITY HAS EXPERIENCED 5 OCCURRENCES OF THIS ISSUE AS WELL AS ONE ISSUE OF TUBING SEPARATING COMPLETELY FROM BARREL. NO SPECIFIC DATE IS KNOWN FOR ANY OF THESE OCCURRENCES. NO BLOOD EXPOSURE, NO MEDICAL INTERVENTION AND NO SAFETY ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203027 ↗
• MalfunctionApr 12, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT AIR BUBBLES FORMING IN TUBE WITH A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE "SYRINGES ARE ALLOWING AIR TO ENTER THE SYRINGE WHEN THEY PULL BACK FOR BLOOD DRAWS WHILE ATTACHED TO BUTTERFLY. I DO NOT HAVE PATIENT INFORMATION OR DATES, I PERSONALLY WITNESSED AIR GOING INTO THE SYRINGE WHEN DRAWING BLOOD ON A FEW OCCASIONS. I INSTRUCTED THE PHLEBOTOMISTS TO QUIT USING THE 5 CC¿S, WE PULLED THAT LOT# AND STARTED USING A DIFFERENT LOT WITH NO ISSUES.

  Patient problems: No Information

  MAUDE report 8508689 ↗
• MalfunctionMar 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391883 ↗
• MalfunctionMar 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN USING A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THE CUSTOMER HAD ABNORMAL RESULTS. THE CUSTOMERS STATEMENT IS AS FOLLOWS, "WE¿RE REACHING OUT BECAUSE WE RAN INTO AN INTERESTING SITUATION WITH A CHILD¿S LEAD TEST RESULT. IT WAS ABNORMALLY HIGH FROM THE FIRST COLLECTION AND BACK TO A NORMAL LEVEL ON A SEPARATE COLLECTION TWO DAYS LATER. WE COULDN¿T FIND ANY REASONS FOR POSSIBLE CROSS-CONTAMINATION DURING TESTING PHASE."

  Patient problems: Test Result

  MAUDE report 8391829 ↗
• MalfunctionMay 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET CONTAINED MANY BLACK SPOTS INSIDE

  Patient problems: No Information

  MAUDE report 7477094 ↗
• MalfunctionApr 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD FOREIGN MATTER INSIDE THE PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448237 ↗
• MalfunctionDec 6, 2017Device Packaging Compromised

  IT WAS REPORTED THAT A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD PRESENCE OF BLOOD INSIDE AND OUTSIDE OF THE PACKAGING. IT WAS REPORTED TO BE HERMETICALLY SEALED. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088010 ↗