BD Vacutainer® Push Button Blood Collection Set 367323Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 30382903673231), received between Apr 26, 2018 and Aug 3, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET CUSTOMER REPORTS LEAKAGE IN THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THEY STILL EXPLICITLY STATE THAT THE LEAKAGE IS THUS AT THE CONNECTION WITH THE BD PUSH BUTTON BLUE BUTTERFLY NEEDLES, REF (B)(4). IT IS AT THAT CONNECTION THAT THEY LEAK. ON CONNECTIONS WITH BD VENFLONS, E.G. REF (B)(4) THEY SAY THEY NEVER HAVE PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455497 ↗
• MalfunctionJun 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET LEAKED AT CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "LEAKAGE AT CONNECTION TAP AND NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144121 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD INCORRECT OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: NON-COMPLIANCE OF THE LABELING FOR BD PRODUCTS SHIPPED TO UKRAINE (LABELING NOT COMPLIANT WITH LOCAL/UKRAINIAN REQUIREMENTS). IDS SM PRODUCTS OF HIGHER CLASSES (INCLUDED ATTACHMENT#1.) WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) ¿ IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000003 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "COMPLAINT: NON-COMPLIANCE OF THE LABELING FOR BD PRODUCTS SHIPPED TO UKRAINE (LABELING NOT COMPLIANT WITH LOCAL/UKRAINIAN REQUIREMENTS) AFFECTED BD PRODUCTS: IDS SM WITH THE LIST OF AFFECTED SKUS IDENTIFIED BY OUR TEAM) WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS. IDS SM PRODUCTS OF HIGHER CLASSES WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000002 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET LABELLING WAS NOT APPROPRIATE WITH UKRAINIAN REQUIREMENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: NON-COMPLIANCE OF THE LABELING FOR BD PRODUCTS SHIPPED TO UKRAINE (LABELING NOT COMPLIANT WITH LOCAL/UKRAINIAN REQUIREMENTS). IDS SM PRODUCTS OF HIGHER CLASSES (INCLUDED ATTACHMENT#1.) WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) ¿ IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992064 ↗
• MalfunctionMay 19, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS." IDS SM PRODUCTS OF HIGHER CLASSES WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) ¿ IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK." ALSO, WE WOULD LIKE TO POINT OUT THAT IN THE PROCEDURE ¿MEDICAL DEVICE AND IN VITRO DIAGNOSTIC MEDICAL DEVICE REQUIRED LABELING CONTENT¿ USED BY THE LABELING TEAM THIS REQUIREMENT IS NOT CAPTURED. THEREFORE, THE SOP ALSO NEEDS TO BE UPDATED AND IMPLEMENTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969406 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE NON PATIENT NEEDLE SEPARATED FROM THE HOLDER LUER/ADAPTOR/HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE MALE LUER PART OF THE CAP BROKE OFF AND GOT STUCK IN THE FEMALE LUER OF THE EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16349116 ↗
• MalfunctionJul 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED FAILURE OF THE PRODUCT TO CONTAIN BLOOD OR MEDICATION. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS TIME THE DEVICE HAD A HOLE/DEFECT IN THE TUBING AND WHILE ATTEMPTING TO COLLECT BLOOD THE BLOOD ONLY MADE IT TO THE DEFECT AREA. THE BLOOD WOULD DRIP OUT OF THE TUBING AND WOULD NOT EVER MAKE IT TO THE SYRINGE RESULTING IN THE PATIENT HAVING TO BE RE-STUCK WITH A SEPARATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110876 ↗
• MalfunctionJul 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED FAILURE OF THE PRODUCT TO CONTAIN BLOOD OR MEDICATION. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER REPORTED A HOLE OR CUT IN THE TUBING OF ITEM 367323 LOT NUMBER 1075990. SHE STATED WHEN THE NEEDLE WAS HOOKED UP TO THE SYRINGE, THE BLOOD WOULD ONLY MAKE IT TO A CERTAIN SPOT IN THE TUBE AND THEN DRIP OUT. THE BLOOD WOULD NOT MAKE IT TO THE SYRINGE BECAUSE OF THE HOLE OR CUT. THEY HAVE ONLY NOTICED THIS ON 2 OF THE TUBES FROM THIS LOT BUT SHE IS HAVING THE STAFF LOOK AT THE REST TO SEE IF THERE ARE MORE. THE CUSTOMER'S BLOOD HAD TO BE REDRAWN BECAUSE OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104288 ↗
• MalfunctionJan 4, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT AIR BUBBLES FORMED WHILE USING A BD VACUTAINER(R) PUSH BUTTON BLOOD COLLECTION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER IS EXPERIENCING AIR COMING IN TO SYRINGE. VERBIAGE RECEIVED, - "SYRINGE IS LETTING AIR THROUGH".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11114255 ↗
• MalfunctionNov 22, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTICED THAT THE DEVICE WAS PARTIALLY ACTIVATED, BUT NOT FULLY RETRACTED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO USE, THE PHLEBOTOMIST NOTICED THAT THE DEVICE WAS PARTIALLY ACTIVATED, BUT HAD NOT FULLY RETRACTED, DUE TO THE FACT THAT THE NEEDLE ITSELF WAS COMPLETELY BENT AND MANGLED, AND WAS ACTUALLY HOOKED TO THE SIDE OF THE DEVICE, WHICH WOULD NOT ALLOW THE NEEDLE TO FULLY RETRACT IN TO THE HOUSING. PICTURES WERE PROVIDED BY THE CUSTOMER, AND LUCKILY, THE PRODUCT WAS NOT MANIPULATED OR USED IN ANY WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366168 ↗
• MalfunctionOct 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE WAS AN ISSUE WITH LEAKAGE AT THE LEVEL OF THE TUBING. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN SETTING UP THE WING FOR THE INJECTION OF RADIOACTIVE PRODUCT, A LEAKAGE IN THE TUBING WAS FOUND. FORTUNATELY THERE WAS NO CONSEQUENCE OF RADIOACTIVE CONTAMINATION BECAUSE TUBING WAS PURGED WITH SALINE. ON THE OTHER HAND, THERE WAS AN OBLIGATION TO PUNCTURE THE PATIENT AGAIN IN ORDER TO ADMINISTER THE CONTRAST PRODUCT. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157729 ↗
• MalfunctionMay 14, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD A LEAKAGE BETWEEN THE NEEDLE AND THE BARREL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7511115 ↗
• MalfunctionMay 1, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD AN "INCORRECT LABEL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7475685 ↗
• MalfunctionApr 26, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WAS LABELED INCORRECTLY AS THE PRODUCT THAT WAS RECEIVED WAS A PUSH BUTTON DEVICE WITHOUT A VACUTAINER.

  Patient problems: No Patient Involvement

  MAUDE report 7464349 ↗