BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder 368659Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382903686590), received between Nov 28, 2017 and Mar 20, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Cut In Material1
- Device Markings/Labelling Problem1
- Fluid/Blood Leak1
- Physical Resistance/Sticking1
- Product Quality Problem1
- Retraction Problem1
- Volume Accuracy Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Needle Stick/Puncture1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE HUB DETACHED EXPOSING THE NEEDLE WHEN THE SAFETY SHIELD WAS ACTIVATED. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21659740 ↗MalfunctionMar 1, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT DURING THE USE OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE BLOOD ENTERS THE TUBING REALLY FAST WHEN THE NEEDLE WAS INSERTED INTO THE PATIENT. THEN WHEN THE VACUTAINER TUBE WAS CONNECTED, IT SHOOTS THE BLOOD IN REALLY QUICKLY AND LOSES ALL PRESSURE; IT STOPS WORKING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18817530 ↗InjuryMay 22, 2023Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT WHEN RETRACTING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE NEEDLE WOULD NOT RETRACT AND A NEEDLE STICK INJURY OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT, AND INFORMATION REGARDING INTERVENTION FOR HEALTHCARE WORKER HAS NOT YET BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING STICKING HERSELF WITH THE NEEDLE WHILE TRYING TO RETRACT IT.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 16981915 ↗MalfunctionJun 19, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER WAS CUT CAUSING A LEAK. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7614037 ↗MalfunctionMay 21, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER WAS CUT. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7530246 ↗MalfunctionApr 16, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PACKAGING FOR THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER CONTAINED MIXED PRODUCTS; 25 GAUGE BUTTERFLIES FOUND IN A 23 GAUGE PACKAGE. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7433306 ↗MalfunctionNov 28, 2017Fluid/Blood Leak; Cut In Material
IT WAS REPORTED THAT TUBING ON THE BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET WAS CUT, RESULTING IN BLOOD LEAKAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7064375 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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