BD Vacutainer® Push Button Blood Collection Set 367335Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Push Button Blood Collection Set · Class 2
All models of BD Vacutainer Push Button Blood Collection Set (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382903673354), received between Nov 27, 2017 and Apr 1, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem2
- Leak/Splash2
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Blood Loss1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPILL IN THE KIDNEY DISH WHILE INTERCHANGING TUBES DUE TO THE NON-PATIENT NEEDLE SLEEVE PUNCTURING AND LEAKING BLOOD. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739258 ↗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 AS AN EXAMPLE PLEASE SEE BELOW THE NEW IFU FOR SKU 367300 (PLEASE FIND ENCLOSED ATTACHMENT#2.) WHICH WAS REGISTERED VIA CONFORMITY ASSESSMENT BODY ¿ THERE IS NO UKRAINIAN CONFORMITY ASSESSME
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17000012 ↗MalfunctionSep 11, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT MIXED PRODUCT OCCURRED BEFORE USE WITH A BD VACUTAINER ® PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN I OPENED THE BOX I NOTICED SOME RED TEXT AND CORNER ARROW ON ONE OF THE DEVICES, IT IS SITUATED AS A SINGULAR ULTRA-TOUCH DEVICE IN THE BOX. CODE 367391 BD VACUTAINER ULTRATOUCH PUSHBUTTON BLOOD COLLECTION SET 25G 7INCH TUBE THE BOX PRODUCT CODE IS 367335 AND LOT NUMBER 8344580. THE BOX WAS SEALED CLOSED BY SUPPLY CHAIN AND HAD NOT BEEN OPENED BEFORE BEING DELIVERED TO MY OFFICE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8994756 ↗MalfunctionNov 29, 2017Crack
IT WAS REPORTED THAT THE PUSH BUTTON BLOOD COLLECTION SET, 7 INCH TUBING, W/LUER ADAPTER, 25 GAUGE HUB WAS CRACKED. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7067732 ↗MalfunctionNov 27, 2017Break; Leak/Splash
IT WAS REPORTED THAT THE 25 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 7 IN. TUBING AND LUER ADAPTER HAD SEVERAL BROKEN PLASTIC CONNECTORS, THIS RESULTED IN BLOOD LEAKS DURING COLLECTION. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: Blood Loss
MAUDE report 7059317 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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