BD Vacutainer® Safety-Lok™ Blood Collection Set 367296Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30382903672968), received between Dec 6, 2017 and Aug 23, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: ERROR ON CERTIFICATE FROM REGDOCS PAGE, WRONG LOT#. CUSTOMER REPORTED AN ERROR WITH THE COA FOR LOT#: 2G1781. ON THE BD WEBSITE REGDOCS THE COA FOR THIS LOT# LIST THE LOT#: 2F1781 CUSTOMER IS REQUESTING THE CORRECT COA FOR LOT#: 2G1781. ISSUE PRODUCT - ERROR ON COA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607877 ↗
• InjurySep 3, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE DEVICE EXPERIENCED DIFFICULTY WHILE TRYING TO ACTIVATE THE SAFETY SHIELD, RESULTING IN A NEEDLESTICK INJURY POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONE OF OUR PHLEBOTOMIST WAS DRAWING A BLOOD CULTURE. SHE USED THE PRE- PACKAGED BC KIT, WHICH INCLUDES THE BLOOD COLLECTION SET ( 21G BUTTERFLY). WHEN SHE WAS DONE USING THE DEVICE SHE ENGAGED THE SAFETY UNTIL IT STOPPED. WHEN SHE WENT TO PICK IT UP TO DISCARD, SHE WAS STUCK BY THE EXPOSED TIP. I EXAMINED THE DEVICE AND THE SAFETY WOULD NOT ADVANCE ANY MORE THAN IT HAD, LEAVING THE TIP OF THE NEEDLE EXPOSED. THERE WAS A SAFE CARE SUBMITTED ON 8/9/21."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422568 ↗
• MalfunctionSep 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF WINGSET SEZSET 21X.75 12 W/O LUER EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE TO INTRAVASCULAR INFUSION WITH SAFETY SYSTEM WITH LEAKAGE/EXTRAVASATION WITH OUTPUT IN THE CONNECTION OF THE PLASTIC TAB WITH THE FLEXIBLE TUBE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9135919 ↗
• MalfunctionJun 19, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET EXPERIENCED A CLOGGED/BLOCKED CANNULA DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367296 BATCH NO. UNKNOWN (PROVIDED LOT 8K1281) IT WAS REPORTED THE THERE WERE CLOGGING. (1 OF 4 - MALE) DATE OF EVENT (B)(6) 2019. THERE WAS ISSUES WITH THE CLOGGING DURING SEVERAL DRAWS. SPOKE WITH THE CUSTOMER AND SHE EXPLAINED THAT THEY WERE USING A 19 GAUGE STRAIGHT NEEDLE WITHOUT ANY SAFETY SHIELD TO CONNECT TO A LUER ADAPTER AND THEN TO A HEPARINIZED 60 ML SYRINGE TO COLLECT 110 ML OF BLOOD FOR A MANUAL FICOLL STUDY. THEY WERE ABLE TO DO THIS SUCCESSFULLY, BUT WOULD LIKE TO START USING A NEEDLE WITH SAFETY FEATURES. THEY TRIED THE 21 GAUGE SLBCS ON 4 PATIENTS AND AFTER 60 ML, THE BLOOD STOPPED FLOWING. SHE EXPLAINED THAT THE PHLEBOTOMIST IS VERY EXPERIENCED AND WOULD KNOW IF THE NEEDLE WAS NOT POSITIONED CORRECTLY IN THE VEIN AND KNOW HOW TO CORRECT THE SITUATION. SHE THOUGHT THAT THE SMALLER BORE NEEDLE MIGHT CAUSE THE BLOOD TO CLOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714404 ↗
• MalfunctionJun 19, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WAS CLOGGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367296 BATCH NO. UNKNOWN (PROVIDED LOT 8K1281) IT WAS REPORTED THE THERE WERE CLOGGING. (4 OF 4) DATE OF EVENT (B)(6) 2019. THERE WAS ISSUES WITH THE CLOGGING DURING SEVERAL DRAWS. SPOKE WITH THE CUSTOMER AND SHE EXPLAINED THAT THEY WERE USING A TERUMO 19 GAUGE STRAIGHT NEEDLE WITHOUT ANY SAFETY SHIELD TO CONNECT TO A LUER ADAPTER AND THEN TO A HEPARINIZED 60 ML SYRINGE TO COLLECT 110 ML OF BLOOD FOR A MANUAL FICOLL STUDY. THEY WERE ABLE TO DO THIS SUCCESSFULLY, BUT WOULD LIKE TO START USING A NEEDLE WITH SAFETY FEATURES. THEY TRIED THE 21 GAUGE SLBCS ON 4 PATIENTS AND AFTER 60 ML, THE BLOOD STOPPED FLOWING. SHE EXPLAINED THAT THE PHLEBOTOMIST IS VERY EXPERIENCED AND WOULD KNOW IF THE NEEDLE WAS NOT POSITIONED CORRECTLY IN THE VEIN AND KNOW HOW TO CORRECT THE SITUATION. SHE THOUGHT THAT THE SMALLER BORE NEEDLE MIGHT CAUSE THE BLOOD TO CLOT. SHE EXPLAINED THAT SHE WOULD NEED TO GO TO ANOTHER COMPANY TO GET A 19 GAUGE SAFETY NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714283 ↗
• MalfunctionJun 19, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS CLOGGING DURING USE WITH A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367296, BATCH NO. 8K1281. IT WAS REPORTED THE THERE WERE CLOGGING. (2 OF 4) DATE OF EVENT (B)(6) 2019. THERE WAS ISSUES WITH THE CLOGGING DURING SEVERAL DRAWS, SPOKE WITH THE CUSTOMER AND SHE EXPLAINED THEY TRIED THE 21 GAUGE SLBCS ON 4 PATIENTS AND AFTER 60 ML, THE BLOOD STOPPED FLOWING. SHE EXPLAINED THAT THE PHLEBOTOMIST IS VERY EXPERIENCED AND WOULD KNOW IF THE NEEDLE WAS NOT POSITIONED CORRECTLY IN THE VEIN AND KNOW HOW TO CORRECT THE SITUATION. SHE THOUGHT THAT THE SMALLER BORE NEEDLE MIGHT CAUSE THE BLOOD TO CLOT. SHE EXPLAINED THAT SHE WOULD NEED TO GO TO ANOTHER COMPANY TO GET A 19 GAUGE SAFETY NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713765 ↗
• MalfunctionJun 19, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THREE WAS AN ISSUE WITH CLOGGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367296 BATCH NO. 8K1281. IT WAS REPORTED THE THERE WERE CLOGGING. (3 OF 4 - FEMALE) DATE OF EVENT (B)(6) 2019. THERE WAS ISSUES WITH THE CLOGGING DURING SEVERAL DRAWS, SPOKE WITH THE CUSTOMER AND SHE EXPLAINED THEY TRIED THE 21 GAUGE SLBCS ON 4 PATIENTS AND AFTER 60 ML, THE BLOOD STOPPED FLOWING. SHE EXPLAINED THAT THE PHLEBOTOMIST IS VERY EXPERIENCED AND WOULD KNOW IF THE NEEDLE WAS NOT POSITIONED CORRECTLY IN THE VEIN AND KNOW HOW TO CORRECT THE SITUATION. SHE THOUGHT THAT THE SMALLER BORE NEEDLE MIGHT CAUSE THE BLOOD TO CLOT. SHE EXPLAINED THAT SHE WOULD NEED TO GO TO ANOTHER COMPANY TO GET A 19 GAUGE SAFETY NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713568 ↗
• MalfunctionNov 7, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THERE WAS AN ISSUE WITH SAFETY SHIELD DIFFICULT TO ACTIVATE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047953 ↗
• MalfunctionOct 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CUSTOMER ORDERED THE WRONG PRODUCT FROM THEIR SUPPLIER. THERE WAS NO ISSUE WITH THE PRODUCT. THIS SUPPLEMENTAL IS TO CANCEL THE MDR SUBMITTED AS THIS IS A NON COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948231 ↗
• MalfunctionJun 12, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SETS ARE NOT WORKING PROPERLY AS BLOOD FLOWS TOO FAST BEFORE THEY CAN EVEN REMOVE TOURNIQUET. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592117 ↗
• MalfunctionDec 7, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET LEAKED BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7098077 ↗
• MalfunctionDec 6, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, W/OUT LUER ADAPTER HAD BLOOD LEAKAGE AT THE LUER. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: Blood Loss

  MAUDE report 7088997 ↗