BD Vacutainer® Push Button Blood Collection Set 367324Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 30382903673248), received between Oct 27, 2017 and Sep 15, 2026 — classified as 4 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (36 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780205 ↗
• MalfunctionSep 9, 2026Material Separation; Volume Accuracy Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697742 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, , LEAKAGE OCCURRED IN 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144517 ↗
• MalfunctionMar 31, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, FOREIGN MATTER WAS FOUND IN THE HUB OF ONE (1) DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737965 ↗
• MalfunctionJan 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, SIX DEVICES EXHIBITED DUST INSIDE OF THE PACKAGING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950116 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS A BLOOD LEAKAGE FROM THE CONNECTION BETWEEN THE BODY AND THE TUBING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185051 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED AFTER COLLECTION WHEN RETRACTING NEEDLE. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345894 ↗
• MalfunctionFeb 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, ONE (1) TUBE HAD A BLACK STAIN ON THE TUBING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321697 ↗
• MalfunctionJan 16, 2025Leak/Splash; Leak/Splash

  REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED WHEN RETRACTING NEEDLE AFTER COLLECTION ON ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173293 ↗
• MalfunctionJan 16, 2025Leak/Splash; Leak/Splash

  REPORT 1 OF 2: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED WHEN RETRACTING NEEDLE AFTER COLLECTION ON ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173292 ↗
• MalfunctionNov 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN INFUSION COULD NOT BE ADMINISTERED DUE TO A CONNECTOR DAMAGED DURING USE. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696541 ↗
• MalfunctionSep 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE TUBE OF THE WINGED NEEDLE HAD BEEN CUT ON ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325824 ↗
• MalfunctionAug 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USING A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN INSECT WAS OBSERVED INSIDE ONE (1) UNUSED WINGSET PACKAGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982734 ↗
• MalfunctionMar 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM SYRINGE AND NON-PATIENT NEEDLE SITE. NO IMPACT REPORTED FOR THE PATIENT AND THE HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924080 ↗
• MalfunctionFeb 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE BLOOD COLLECTION TUBE WAS TORN. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624355 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT BLOOD LEAKED WHILE COLLECTING BLOOD WITH THE PUSH BUTTON OF THE WINGED NEEDLE (23G).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17910495 ↗
• MalfunctionAug 16, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET CUSTOMER REPORTS THAT THEY'VE FOUND CRUSHED AND THIN TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THAT THE PRODUCT (WINGSET 23G) FOUND WITH CRUSHED AND THINNED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560449 ↗
• MalfunctionJun 5, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 2 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS INSUFFICIENT BLOOD FLOW THROUGH THE DEVICE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXPECTATION IS WHEN YOU ARE USING THE BUTTERFLY NEEDLE, THE ATTACHED BLOOD DRAWING TUBE IS ATTACHED TO THE ADAPTER AND THE TUBES FILL WITHOUT ANY ISSUES, WHAT WE ARE SEEING IS THAT THE BLOOD IS SEEN IN THE TUBING AND GOING VERY SLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061475 ↗
• MalfunctionMay 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT BLOOD LEAKAGE OCCURRING DURING THE USE OF WINGSET PBBCS 23G.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989166 ↗
• MalfunctionMay 23, 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 16988948 ↗
• MalfunctionMay 2, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP AND FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD LEAKAGE OCCURRED DURING BLOOD COLLECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856143 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP AND FAILURE OF THE PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS BLOOD LEAKAGE FROM A DAMAGE ON THE TUBING THAT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744049 ↗
• MalfunctionApr 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE TUBING BEFORE USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675160 ↗
• MalfunctionMar 29, 2023Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD LEAKAGE FROM DAMAGE ON THE TUBING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638015 ↗
• MalfunctionFeb 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS BLOOD LEAKAGE OCCURRING DURING THE USE OF WINGET PBBCS. THERE WAS NO MEDICAL INTERVENTIONS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389675 ↗