BD Vacutainer® PPT™ Plasma Preparation Tube K2E 9.0 mg 362788Recalls & reported problems
Becton, Dickinson And Company · TUBE PPT PLH 13X100 5.0 MLBL PWHT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer PPT tube prepares plasma from blood for DNA testing. Its 377 reports often describe foreign matter, gel air bubbles or contamination inside the tubes, and leaks. Some describe incorrect or inadequate test readings. The reports include no injuries and no deaths. Reports fell from 76 in the previous 12 months to 12 in the last 12 months. 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
- 378
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 378 adverse event reports that list this exact device (DI 30382903627883), received between Nov 27, 2017 and Sep 30, 2026 — classified as 378 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (90 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
- Device Contamination with Chemical or Other Material90
- Incorrect, Inadequate or Imprecise Result or Readings86
- Device Ingredient or Reagent Problem55
- Leak/Splash44
- Incorrect Or Inadequate Test Results39
- Material Deformation29
- Component Missing16
- Short Fill16
Patient problems
- No Clinical Signs, Symptoms or Conditions197
- No Known Impact Or Consequence To Patient120
- No Consequences Or Impact To Patient39
- No Information14
- No Patient Involvement9
Recent adverse event reports
The 25 most recent of 378 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954898 ↗MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860012 ↗MalfunctionMar 31, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, A FIBROUS WHITE FOREIGN MATTER WAS SEEN INSIDE OF TWO TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749066 ↗MalfunctionMar 10, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED AFTER USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, FOREIGN MATTER WAS FOUND 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 24562762 ↗MalfunctionFeb 5, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 11 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273744 ↗MalfunctionFeb 4, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 100 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260140 ↗MalfunctionJan 22, 2026Contamination
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, WHITE CLUMPED FOREIGN MATTER WAS FOUND IN TWENTY (20) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147172 ↗MalfunctionDec 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES CONTAINED BLACK FOREIGN MATTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688851 ↗MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF TUBES HAD A FOREIGN BODY INSIDE THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623810 ↗MalfunctionNov 13, 2025Short Fill; Short Fill
IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 1 TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551067 ↗MalfunctionNov 11, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG DURING A STUDY, 4 SAMPLES FROM THE SAME PATIENT EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528407 ↗MalfunctionNov 11, 2025Material Discolored; Device Markings/Labelling Problem; Material Discolored; Device Markings/Labelling Problem
REPORT 3 OF 3: IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG,,1 TUBE HAD NO LABEL AND 4 CAPS WERE DISCOLORED. FOREIGN MATTER OUTSIDE OF THE TUBE WAS ALSO REPORTED ON TUBE AND EMBEDDED IN THE SHIELD. WRINKLED TUBE LABELS WAS ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528404 ↗MalfunctionNov 11, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG , 13 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526965 ↗MalfunctionSep 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
REPORT 1 OF 3: IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG,, 1 TUBE CONTAINED FOREIGN MATTER (CLUMPS). FOREIGN MATTER OUTSIDE OF THE TUBE WAS ALSO REPORTED ON TUBE AND EMBEDDED IN THE SHIELD. WRINKLED TUBE LABELS WAS ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23115275 ↗MalfunctionSep 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
REPORT 2 OF 3: IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG,, 8 TUBES CONTAINED EMBEDDED FOREIGN MATTER. FOREIGN MATTER OUTSIDE OF THE TUBE WAS ALSO REPORTED ON TUBE AND EMBEDDED IN THE SHIELD. WRINKLED TUBE LABELS WAS ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23114343 ↗MalfunctionSep 18, 2025Premature Separation; Premature Separation
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 20 TUBES HAD A COCKED STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23091911 ↗MalfunctionSep 16, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 89 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23067229 ↗MalfunctionSep 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES CONTAINED BLACK FOREIGN MATTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065174 ↗MalfunctionSep 10, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
REPORT 2 OF 2: IT WAS REPORTED AFTER PROCESSING TUBES USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES EXHIBITED POOR PLASMA AND SEPARATION WHERE THERE WERE RBC'S IN THE PLASMA ABOVE THE GEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019108 ↗MalfunctionSep 10, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
REPORT 1 OF 2: IT WAS REPORTED AFTER COLLECTION BUT PRIOR TO PROCESSING USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018305 ↗MalfunctionSep 9, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED DURING A STUDY WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000221 ↗MalfunctionSep 9, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED DURING A STUDY WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 2 TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000209 ↗MalfunctionSep 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER ON TOP OF THE GEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22969149 ↗MalfunctionAug 18, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 1 SAMPLE EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836176 ↗MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 1 TUBE HAD FOREIGN MATTER INSIDE AND OUTSIDE THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835407 ↗
Other Blood/plasma collection device for DNA testing devices
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- Vacuette 456003Greiner Bio-One GmbH · Blood/plasma collection device for DNA testing1 recall0 reports
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- Vacuette 454021Greiner Bio-One GmbH · Blood/plasma collection device for DNA testing1 report
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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