BD Vacutainer® Push Button Blood Collection Set 367341Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 30382903673415), received between Nov 30, 2017 and Jul 28, 2025 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE DID NOT FULLY RETRACT AFTER PRESSING THE BUTTON. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636707 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE RUBBER COVERING THE NON-PATIENT NEEDLE HAD A BULGE CAUSING BLOOD TO LEAK FROM THE NEEDLE WHILE DRAWING BLOOD ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412900 ↗
• MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, FIVE (5) SETS HAD HOLES IN THE TUBING WHICH LED TO BLOOD LEAKAGE. SAMPLE RECOLLECTION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844153 ↗
• MalfunctionNov 20, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED UNSPECIFIED NUMBER OF UNITS HAD PINHOLES IN THE TUBING AND ARE LEAKING BLOOD. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734088 ↗
• MalfunctionOct 23, 2024Leak/Splash; Leak/Splash

  REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER EXPERIENCED BLOOD FLOW COMING OUT OF THE LINE, UPON INSPECTION OF THE TUBING, THEY FOUND A PERFORATED HOLE ON UNSPECIFIED NUMBER OF TUBING. TWO (2) PATIENTS SAMPLES HAD TO BE RECOLLECTED, NO OTHER PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515916 ↗
• MalfunctionOct 23, 2024Leak/Splash; Leak/Splash

  REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER EXPERIENCED BLOOD FLOW COMING OUT OF THE LINE, UPON INSPECTION OF THE TUBING, THEY FOUND A PERFORATED HOLE ON UNSPECIFIED NUMBER OF TUBING. TWO (2) PATIENTS SAMPLES HAD TO BE RECOLLECTED, NO OTHER PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515614 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS ONE (1) DEFECTIVE TUBING, BLOOD LEAKED FROM TUBING ONCE BLOOD WAS DRAWN AND AT TIMES THE PATIENT HAS TO BE STUCK AGAIN. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463729 ↗
• MalfunctionOct 11, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED ONCE BLOOD WENT INTO THE TUBING, AND AT TIMES THE PATIENT HAS TO BE STUCK AGAIN. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431005 ↗
• MalfunctionSep 18, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS BLOOD LEAKAGE. THIS OCCURRED ON BETWEEN 7 AND 10 WING SETS. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251754 ↗
• MalfunctionSep 11, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, (1) WINGSET HAD HOLES IN THE TUBING LEADING TO LEAKAGE AND UNDERFILL. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195336 ↗
• MalfunctionJul 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE NEEDLE WAS CROOKED AND THE TUBE BROKE, THUS RESULTING IN LEAKAGE. THERE WAS NO REPORT OF SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661237 ↗
• InjuryAug 14, 2023Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET CUSTOMER REPORTS THAT THE NEEDLE ON PUSH BUTTON DID NOT FULLY RETRACT AND EMPLOYEE WAS STUCK ACCIDENTALLY. INFORMATION REGARDING INTERVENTION WAS NOT OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE ON PUSH BUTTON DID NOT FULLY RETRACT AND EMPLOYEE WAS STUCK ACCIDENTALLY. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES IF YES¿DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: NEEDLE ON PUSH BUTTON DID NOT FULLY RETRACT AND EMPLOYEE WAS STUCK ACCIDENTALLY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17545715 ↗
• MalfunctionJun 22, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS A RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING NEEDLE NOT RETRACTING WHEN BUTTON WAS PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183126 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS A LABEL ISSUE. 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) AFFECTED BD PRODUCTS: IDS SM (PLEASE FIND ATTACHMENT#1. WITH THE LIST OF AFFECTED SKUS IDENTIFIED BY OUR TEAM) LEGAL MANUFACTURER: BECTON, DICKINSON AND COMPANY, 1 BECTON DRIVE, FRANKLIN LAKES, NJ 07417-1855, USA DESCRIPTION: WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH 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 UKRAINIAN CONFORMITY MARK: UKRAINIAN CONFORMITY MARK WITH CONFORMITY ASSESSMENT BODY NUMBER: AS AN EXAMPLE PLEASE SEE BELOW THE NEW IFU FOR SKU 367300 (PLEASE FIND ENCLOSED ATTACHMENT#2.) WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000049 ↗
• MalfunctionApr 12, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS AIR BUBBLES FORMING IN THE TUBING AND PREVENTING THE TUBES FROM FILLING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE AIR BUBBLES IN THE TUBE BEFORE BLOOD GETS TO HUB OR DURING TRANSFER WITHOUT THE NEEDLE LEAVING THE VEIN. IT RUNS TO THE HUB AND EVENTUALLY INTO COLLECTION TUBE, THEN THE BLOOD EITHER SLOWS DOWN OR STOPS COMPLETELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727184 ↗
• MalfunctionApr 5, 2022Material Discolored; Material Discolored

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE TUBING MATERIAL WAS DISCOLORED. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE PIPELINE IS NOT NORMAL TRANSPARENT COLOR, AND IT IS YELLOWISH TO THE NAKED EYE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017432 ↗
• MalfunctionAug 9, 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: IT WAS REPORTED THAT THE BUTTERFLY TUBING HAD A PUNCTURE IN IT. WHILE DRAWING BLOOD FROM PATIENT BUTTERFLY TUBING STARTED DRIPPING BLOOD ONTO BED/NURSE. IT WAS NOTED BUTTERFLY TUBING HAD PUNCTURE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12295738 ↗
• MalfunctionJun 4, 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: PIR VERBIAGE RECEIVED, - "BLOOD LEAVING FROM HUB. APPEARS CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941290 ↗
• MalfunctionApr 26, 2021Contamination; Contamination

  IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FOREIGN MATTER ON DEVICE / NEEDLE/ TUBING OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SECTION OF TUBING APPEARS DISCOLOURED WITH DARK RESIDUE INSIDE, TEM PULLED FROM LAB AND OTHER KITS FROM SET CHECKED FOR SAME ISSUE. NO OTHER ISSUES NOTED FROM SAME BOX."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729753 ↗
• MalfunctionOct 20, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3 COMPLAINTS). MEDLINE REPORTED ISSUE: BUTTERFLIES THAT DETACHED FROM THE HUB STAFF MEMBERS NOTE THAT THE BD BUTTERFLY NEEDLES COME DETACHED FROM THE NEW NEEDLE HOLDERS WHILE THEY ARE DRAWING BLOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706618 ↗
• MalfunctionFeb 27, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE LEAKAGE OCCURS WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED THAT CUSTOMER EXPERIENCING LEAKING IN TUBING WHEN USING PRODUCT. NO EXPOSURE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763447 ↗
• MalfunctionNov 22, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET NEEDLE DID NOT RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367341, BATCH NO. 9091633. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. AFTER BLOOD DRAW, PHLEBOTOMIST PRESSED BUTTON TO RETRACT NEEDLE (SAFETY FEATURE) AND THE NEEDLE DID NOT RETRACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9361635 ↗
• MalfunctionApr 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD A HOLE IN THE TUBING AND LEAKED BLOOD. THIS OCCURRED ON 2 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367341, BATCH NO: 8288579. IT WAS REPORTED THERE WAS A HOLE IN THE TUBING CAUSING BLOOD TO LEAK OUT AND CAUSE AN EXPOSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522826 ↗
• MalfunctionApr 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS A HOLE IN THE WINGSET TUBING THAT IS CAUSING BLOOD LEAKAGE. THERE WERE TWO OCCURRENCES. MATERIAL NO. 367341, BATCH NO. 8288579. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HOLE IN WINGSET TUBING THAT IS CAUSING BLOOD LEAKAGE''. QUOTED FROM CLINICIAN: "A NURSE ON EP 4-7 WHEN DRAWING BLOOD ON ONE OF HER PATIENTS WAS UNABLE TO OBTAIN THE BLOOD DUE TO A MINIATURE HOLE HALFWAY DOWN THE TUBING OF THE NEEDLE SYSTEM. THE BLOOD FROM THE PATIENT, INSTEAD OF GOING INTO THE TUBE CAME OUT OF THE HOLE AND CAUSED A BLOOD SPILL. THE NURSE TRIED ANOTHER 25 G BUTTERFLY NEEDLE FROM THE SAME LOT AND FOUND THE SAME ISSUE. THIS CAUSED THE PATIENT TO REQUIRE REPEAT VENIPUNCTURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495772 ↗
• MalfunctionFeb 20, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT HERE WAS A NEEDLE SICK INJURY WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, POST USE. "CLINICIAN WASN'T SURE HOW IT HAPPENED BUT KNOWS IT WAS AFTER USE, EITHER DURING THE DISPOSABLE OR IMMEDIATELY AFTER THE ACTIVATION. CLINICIAN SOUGHT TREATMENT FROM EMPLOYEE HEALTH AFTER THE NEEDLE STICK INCIDENT."

  Patient problems: Needle Stick/Puncture

  MAUDE report 8356054 ↗