BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units 367961Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 30382903679615), received between Oct 27, 2017 and Jun 22, 2026 — classified as 6 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Short Fill” (29 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 12, 2019Class IITerminated

   False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

   Z-2302-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Separation Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS, THE STOPPER OF 1 TUBE CAME OFF WHILE APPLYING A LABEL TO THE TUBE AND THE CONTENTS SPILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577980 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 4 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438001 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 15 OF 18: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437998 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 10 OF 18: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437997 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 9 OF 18: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437996 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 5 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437993 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 7 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437991 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 2 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437990 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 6 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437989 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 1 OF 18: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437988 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 16 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437987 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 14 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437985 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 17 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437984 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 18 OF 18 IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437983 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 12 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437982 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 11 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437981 ↗
• MalfunctionJun 8, 2026Short Fill

  REPORT 13 OF 18. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 65 UNITS, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. A NEW TUBE WAS SELECTED TO COMPLETE THE DRAW AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437688 ↗
• MalfunctionJun 5, 2026Short Fill

  1 OF 2 REPORT. IT WAS REPORTED BY CUSTOMER THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 65 UNITS BLOOD COLLECTION TUBES, UNSPECIFIED NUMBER OF TUBES DUE TO INSUFFICIENT NEGATIVE PRESSURE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418132 ↗
• MalfunctionJun 5, 2026Short Fill

  2 OF 2 REPORT. IT WAS REPORTED BY CUSTOMER THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 65 UNITS BLOOD COLLECTION TUBES, UNSPECIFIED NUMBER OF TUBES DUE TO INSUFFICIENT NEGATIVE PRESSURE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417654 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS, THERE WAS POOR SAMPLE QUALITY WITH PARTICULATE MATTER IN THE PLASMA OF AN UNSPECIFIED NUMBER OF DEVICES. TUBES THAT ARE RE-CENTRIFUGED BEGIN TO SHOW ELEVATED TEST RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479162 ↗
• MalfunctionJun 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS, THERE WAS POOR SAMPLE QUALITY WITH PARTICULATE MATTER IN THE PLASMA OF AN UNSPECIFIED NUMBER OF DEVICES. TUBES THAT ARE RE-CENTRIFUGED BEGIN TO SHOW ELEVATED TEST RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349616 ↗
• MalfunctionJul 11, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES THAT ONE TUBE IS UNDERFILLED. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING THAT ITEM 367961 HAVE BEEN FILLING VERY SLOWLY AND WHEN THEY DO, IT'S A SHORT-FILL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300584 ↗
• MalfunctionJun 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES HAVE BEEN GETTING FALSE POSITIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY HAVE BEEN GETTING FALSE POSITIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057102 ↗
• MalfunctionDec 14, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES WERE UNDER FILLING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE UNDERFILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003284 ↗
• MalfunctionDec 8, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE DISCOVERED THAT SOME OF OUR 3.5ML LITHIUM HEPARIN TUBES ARE NOT FILLING COMPLETELY WHICH IS AN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961937 ↗