BD Vacutainer® Push Button Blood Collection Set 367326Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 30382903673262), received between Oct 20, 2017 and Jun 11, 2025 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE RETRACTION BUTTON FOUND TO BE PRESSED FROM THE START AND THE TUBING WAS CUT IN THE MIDDLE OF ONE DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185688 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE RETRACTION BUTTON FOUND TO BE PRESSED FROM THE START AND THE TUBING WAS CUT IN THE MIDDLE OF ONE DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185071 ↗
• 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 HOLDER CONNECTION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183892 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED ALL OVER THE HOLDER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183866 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING TWO BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED DAMAGED IN THE TUBING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183410 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED OUT FROM THE WINGED NEEDLE PUSH BUTTON. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803530 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS A BLOOD LEAK. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328814 ↗
• MalfunctionNov 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAS BEEN FOUND EXPERIENCING BLOOD LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT BLOOD LEAK. A CUSTOMER POINTED OUT THAT THERE WAS BLOOD LEAKAGE DURING BLOOD COLLECTION WITH THE PUSH BUTTON (21G) OF THE WINGED NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093714 ↗
• MalfunctionMay 24, 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 17000011 ↗
• MalfunctionMay 23, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THE ADAPTER CANNOT BE INSERTED BEFORE BLOOD COLLECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE CUSTOMER FOUND THAT THE ADAPTER CANNOT BE INSERTED BEFORE BLOOD COLLECTION. PERHAPS A PART MAY BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989238 ↗
• MalfunctionSep 27, 2022Premature Activation; Material Split, Cut or Torn; Premature Activation; Material Split, Cut or Torn

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED FAILURE OF THE PRODUCT TO CONTAIN BLOOD. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED ABOUT CUT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492275 ↗
• MalfunctionSep 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED CUT TUBING. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED ABOUT CUT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492222 ↗
• MalfunctionSep 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED CUT TUBING. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED ABOUT CUT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15489410 ↗
• MalfunctionSep 2, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS INCORRECT LABEL INFORMATION. THIS EVENT OCCURRED 32 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE BARCODE WAS SCANNED, 32 OF 53 PRODUCTS (CAT#367326) FROM LOT#2021683 SHOWED THE EXPIRATION DATE DISPLAYED AS 2024/01/30. IT SHOULD BE 2024/01/31."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351253 ↗
• MalfunctionJun 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD SPLATTER/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: "DURING THE RETRACTION OF THE NEEDLE, BLOOD SPLASHED AT THE SPRING. SUBSEQUENTLY, SEVERAL FDIS OBSERVED THE SAME PHENOMENON: BLOOD SPLASHED ONTO GLOVES WHEN THE NEEDLE WAS RETRACTED." THERE WAS NO REPORTS OF EXPOSURE OR MEDICAL INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877347 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED BLOOD LEAKAGE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THAT BLOOD LEAKAGE OCCURRED DURING BLOOD COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783684 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED BLOOD SPLATTER / LEAKAGE OR SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THAT BLOOD LEAKAGE OCCURRED DURING BLOOD COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783474 ↗
• MalfunctionAug 26, 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S REPORT, THE TUBING WAS FOUND TO BE CUT BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374020 ↗
• MalfunctionJun 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "BLOOD LEAKAGE DUE TO A HOLE IN THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013031 ↗
• MalfunctionMar 17, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET NON PATIENT NEEDLE SEPARATED FROM THE HOLDER. "MATERIAL NO. 367326, BATCH NO. UNKNOWN. IT IS REPORTED CUSTOMER EXPERIENCED NEEDLE SEPARATING. VERBIAGE RECEIVED FROM PIR SUBMISSION, - "NEEDLE SHOT OUT THE END OF THE WINGSET ON TO THE FLOOR WHILE THE BUTTERFLY WAS STILL IN THE HAND OF THE CLINICIAN." ON 01-MARCH-2021: PIR STATES PHOTO IS AVAILABLE AND THAT SAMPLE WILL BE SENT IN BUT BD REP RICHARD COOPER DID NOT ATTACH PHOTO NOR FILL OUT FACILITY'S MAILING ADDRESS TO SEND FEDEX LABEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510026 ↗
• MalfunctionMar 17, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET NON PATIENT NEEDLE SEPARATED FROM THE HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367326 BATCH NO. 0337059 IT WAS REPORTED THAT THE NEEDLE SHOT OUT OF THE WINGSET. PER EMAIL: TODAY (B)(6) 2021 I WAS DRAWING A PATIENT AS I WENT TO END THE DRAW AND SAFETY MY NEEDLE. THE NEEDLE SHOT OUT OF THE END AND I WAS LEFT HOLDING THE WING OF THE BUTTERFLY WHILE THE NEEDLE FELL TO THE FLOOR. NO ONE WAS HURT OR STUCK. I TOOK A PICTURE OF THE BUTTERFLY AND ATTACHED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510025 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE WITH 20 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER FOUND A DAMAGED TUBING BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 10645445 ↗
• MalfunctionSep 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION (I.E CRACK OR HOLE IN THE SYRINGE, CUT, ETC). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THE "DEVICE WAS FOUND TO HAVE A DEFECTIVE CONNECTOR AND TUBING. THE PRODUCT WAS REJECTED IN OUR PRODUCTION LINE BY AN OPERATOR."

  Patient problems: No Patient Involvement

  MAUDE report 10561081 ↗
• MalfunctionAug 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FAILED TO CONTAIN BLOOD OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND THAT THE TUBING WAS PARTLY DAMAGED. BD IS REQUIRED TO REPLACE THE COMPLAINT PRODUCT AND SUBMIT A CLOSURE LETTER ABOUT THE CAUSE(S)."

  Patient problems: No Patient Involvement

  MAUDE report 10417965 ↗
• MalfunctionAug 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE THE TUBING WAS DISCOVERED TO BE SLICED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER RECEIVED A WINGSET WITH SEVERED TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 10414618 ↗