BD Vacutainer® Serum Blood Collection Tubes 367815Recalls & reported problems
Becton, Dickinson And Company · Tube PLN PLH 13X100mm 6.0ml PLBL RD · Class 2
All models of BD Vacutainer Serum Blood Collection Tubes (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer serum blood collection tube is used to collect blood samples for testing. Its 461 reports mostly describe tube contamination, stoppers popping off and leaking, underfilled tubes and labeling problems. There are no deaths and no injuries, and reports fell to 37 in the last 12 months from 116 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 462
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 462 adverse event reports that list this exact device (DI 30382903678151), received between Nov 4, 2017 and Sep 30, 2026 — classified as 462 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (84 reports).
11 other recalls cover devices cleared under the same FDA submission (BK050036, K981013); they may or may not involve this specific model.
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
- Device Contamination with Chemical or Other Material84
- Leak/Splash63
- Device Ingredient or Reagent Problem61
- Incorrect, Inadequate or Imprecise Result or Readings58
- Device Markings/Labelling Problem51
- Separation Problem30
- Short Fill23
- Fluid/Blood Leak17
Patient problems
- No Clinical Signs, Symptoms or Conditions258
- No Known Impact Or Consequence To Patient123
- No Consequences Or Impact To Patient45
- No Patient Involvement35
- No Information8
Recent adverse event reports
The 25 most recent of 462 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Separation Problem
Report 2 of 2It was reported that when using the BD Vacutainer® Serum Blood Collection Tubes, six (6) tubes exhibited the stopper popping out of the tube, resulting in blood spillage. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946956 ↗MalfunctionSep 30, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946955 ↗MalfunctionSep 29, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939009 ↗MalfunctionMay 13, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165369 ↗MalfunctionMar 25, 2026Separation Problem; Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE STOPPER POPS OUT OF AN UNSPECIFIED NUMBER OF TUBES RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691600 ↗MalfunctionMar 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, FOREIGN MATTER- SPOTS WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593793 ↗MalfunctionMar 11, 2026Separation Problem
IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THERE WERE STOPPER POPS WITH LEAKAGE OFF SEEN IN TEN (10) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574352 ↗MalfunctionMar 10, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564105 ↗MalfunctionMar 10, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, INSUFFICIENT VACUUM WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564102 ↗MalfunctionFeb 18, 2026Contamination
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377620 ↗MalfunctionFeb 18, 2026Contamination
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377616 ↗MalfunctionFeb 17, 2026Separation Problem; Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE LIDS OF ONE BOX OF TUBES ARE LOOSE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365841 ↗MalfunctionJan 26, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, DECREASED VACUUM WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184872 ↗MalfunctionJan 14, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 28 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075277 ↗MalfunctionJan 14, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 79 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075276 ↗MalfunctionJan 14, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 16 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075274 ↗MalfunctionJan 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 6 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063091 ↗MalfunctionJan 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 227 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063076 ↗MalfunctionJan 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 285 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063075 ↗MalfunctionJan 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 1710 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063074 ↗MalfunctionJan 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE PARTICLES WERE SEEN IN 135 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063073 ↗MalfunctionJan 7, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, PARTICULATE MATTER WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995400 ↗MalfunctionJan 5, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ABNORMAL ADDITIVE WAS SEEN WITH ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968043 ↗MalfunctionJan 5, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE BLACK PARTICLES IN ONE CASE OF TUBES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23964348 ↗MalfunctionDec 24, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THE LID WAS LOOSE ON AN UNSPECIFIED AMOUNT OF TUBES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889372 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under BK050036, K981013. One submission often covers many models, so check the product and lot details in each record.
- Z-1618-2022 · May 25, 2022 · Open, Classifieda. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/
- Z-1141-2018 · Mar 22, 2018 · TerminatedBD Vacutainer EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894
- Z-1139-2018 · Mar 22, 2018 · TerminatedBD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 503829036
- Z-0968-2018 · Aug 29, 2017 · TerminatedBD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing an
- Z-0568-2016 · Dec 3, 2015 · TerminatedBD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA BD Vacutainer tubes are used
- Z-0567-2016 · Dec 3, 2015 · TerminatedBD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Pla
- Z-0569-2016 · Dec 3, 2015 · TerminatedBD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer tubes are u
- Z-0570-2016 · Dec 3, 2015 · TerminatedBD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer tubes are used t
- Z-0571-2016 · Dec 3, 2015 · TerminatedBD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer tubes are u
- Z-0456-2016 · Nov 17, 2015 · TerminatedBD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes
- Z-2434-2015 · Jun 23, 2015 · TerminatedBD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page