BD Vacutainer® PPT™ Plasma Preparation Tubes K2E 15.8 mg 362799Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 30382903627999), received between Nov 27, 2017 and Sep 22, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860013 ↗
• MalfunctionMar 10, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED AFTER USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, FOREIGN MATTER 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 24562618 ↗
• MalfunctionDec 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG, THERE IS A DISCREPANCY BETWEEN THE INSTRUCTIONS FOR USE (IFU) AND LABELING. THE CUSTOMER REPORTED THAT THE IFU STATES THAT THE SAMPLE IS TO BE PROCESSED WITHIN 2 HOURS OF COLLECTION WHILE THE PRODUCT LABEL STATES THAT THE SAMPLE IS TO BE PROCESSED WITHIN 6 HOURS OF COLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716173 ↗
• MalfunctionSep 2, 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 TUBES K2E 15.8 MG, 1 TUBE CONTAINED FOREIGN MATTER IN THE GEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940204 ↗
• MalfunctionAug 15, 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 TUBES K2E 15.8 MG, ONE TUBE CONTAINED A HAIR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815642 ↗
• MalfunctionJul 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 4 OF 4, IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, POOR GEL QUALITY WAS 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 22592077 ↗
• MalfunctionJul 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 3 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, POOR GEL QUALITY WAS 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 22591953 ↗
• MalfunctionJul 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 2 OF 4 IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, POOR GEL QUALITY WAS 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 22591906 ↗
• MalfunctionJul 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 1 OF 4, IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, POOR GEL QUALITY WAS 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 22591902 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, GEL AIR BUBBLES WERE OBSERVED AS FOLLOWS: LOT 3222674- 75 TUBES; LOT 3317909 - 10 TUBES; LOT 3289116 - 4 TUBES; LOT 3257655 - 25 TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639962 ↗
• MalfunctionJan 12, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THAT THE USER FOUND, PRIOR TO USE, TWO TUBES WITH ABNORMAL ADDITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507604 ↗
• MalfunctionOct 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG, THERE WERE AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BLOOD DONATION TEAMS ARE ISOLATING EFFECTED TUBES THAT THEY IDENTIFY WITHIN THE STOCK FOUND IN THEIR STOCKS ON A DAILY BASIS AND ALTHOUGH NUMBERS ARE STILL LOW, AIR IN GEL HAS NOW BEEN SEEN IN THE FOLLOWING LOTS: 2321329, 3111753, 3111754, 3111755, 3111756.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007271 ↗
• MalfunctionAug 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. PATIENT 4 OF 5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: (B)(6). ON (B)(6) 2023 IT WAS NOTICED AT THE ...LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT ... FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545232 ↗
• MalfunctionAug 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. PATIENT 5 OF 5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: (B)(6). ON (B)(6) 2023 IT WAS NOTICED AT THE ...LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT ... FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545148 ↗
• MalfunctionAug 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. PATIENT 2 OF 5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS:(B)(6). ON 09 JUNE 2023 IT WAS NOTICED AT THE ...LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT ... FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545133 ↗
• MalfunctionAug 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. PATIENT 3 OF 5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: (B)(6). ON (B)(6) 2023 IT WAS NOTICED AT THE ...LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT ... FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545109 ↗
• MalfunctionAug 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 1 OF 5: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: B03872364205822. ON 09 JUNE 2023 IT WAS NOTICED AT THE CSL PLASMA LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT 131700 FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED. DATE OF RECEIPT AT CSL PLASMA LABORATORY WAS 07 JUNE 2023."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545093 ↗
• MalfunctionJun 30, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED WITH USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THERE WERE ERYTHROCYTES IN THE GEL OF ONE TUBE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ERYTHROCYTES IN GEL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242110 ↗
• MalfunctionJun 28, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG WERE MISSING VACUUM AND NOT FILLING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN 14 OF 7600 TUBES USED SO FAR, THERE HAVE BEEN PROBLEMS WITH THE BLOOD COLLECTION (MISSING VACUUM). THE TUBES WERE NOT FILLED PROPERLY AND THEREFORE CANNOT BE USED FOR MOLECULAR VIRUS DETECTION OF THE BLOOD DONATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218778 ↗
• MalfunctionAug 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORT THAT BEFORE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THERE WAS FOREIGN MATERIAL STUCK ONTO INNER WALL OF 8.5ML PPT TUBE. THIS OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND A FOREIGN MATERIAL STUCK ONTO THE INNER WALL OF 8.5ML PPT TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276968 ↗
• MalfunctionMar 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THERE WERE AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED 30 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN OPENING THE PACKAGE, GEL AIR BUBBLES WERE FOUND IN THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13738546 ↗
• MalfunctionFeb 18, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG, THE USER COMPLAINT OF THE INSTRUMENTS CLOGGING WITH MICRO-CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAD A CALL FROM OUR CLIENT AND THEY HAVE RAISED AN ISSUE WITH RECENTLY RECEIVED 362799 TUBES. SINCE AROUND OCTOBER LAST YEAR (THEY¿VE BEEN USING THESE BD TUBES FOR YEARS) THEY¿VE NOTICED THAT THEIR INSTRUMENTS STARTED CLOGGING WITH MICRO CLOTS OR FIBRIN. THESE FORMATIONS ARE NOT VISIBLE TO THE NAKED EYE, BUT THEY ACCUMULATE IN THE INSTRUMENT NEEDLE AND CLOG IT IN TIME. IT¿S FROM ONE DEPARTMENT WHERE DONORS ARE TESTED, SO FIRST THING THE PERSONNEL HAS BEEN DEBRIEFED AND RECEIVED ADDITIONAL TRAINING TO RECAP THE CORRECT BLOOD COLLECTION WITH THE EMPHASIS ON THE INVERSIONS, EVEN A SHAKER/ROTATOR HAS BEEN PLACED ON SITE TO MIX THE BLOOD STRAIGHT AFTER COLLECTION, HOWEVER NOTHING HAS CHANGED. I AM SENDING SOME PICTURES OF THE PART SHOWING THE DIRT. IT DEFINITELY IS FIBRIN, AS THEY¿VE ASKED PATHOLOGY LAB TO INVESTIGATE IT AND THEY CONFIRMED THIS WAS FIBRIN. NOTHING CAN BE SEEN WITH A NAKED EYE IN THE TUBES AFTER CENTRIFUGATION BEFORE ANALYSIS. SOMETI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560566 ↗
• MalfunctionFeb 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THE CAP WAS DISCOVERED TO BE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND ONE PPT TUBE WHICH HAS A CRACK ON ITS HEMOGARD CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314383 ↗
• MalfunctionJan 18, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THERE WAS "OBSERVATION OF FIBRIN AND CLOT PARTICLES AFTER MELTING THE FROZEN TUBES. THESE TUBES COLLECTED DEPEND ON INSTRUCTION FOR USE THESE TUBES, WE CHECKED THE PROCESS OF WORKFLOW AND CHECK THE QC OF THE CENTRIFUGE THEY USE AND EVERYTHING WAS ACCEPTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11186835 ↗
• MalfunctionOct 28, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH A BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG SAMPLE CLOTTED. THIS OCCURRED ON 10 OCCASIONS, HOWEVER, PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER THE CENTRIFUGATION PROCESS, THE SERUM SAMPLE IS OBTAINED AS A CLOT, WHICH DOES NOT ALLOW THE SEPARATION OF THE SERUM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751672 ↗