BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes 367874Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 30382903678748), received between Apr 23, 2018 and Jun 4, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Short Fill” (19 reports).

2 other recalls cover devices cleared under the same FDA submission (K252040, K944566); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Short Fill

  IT WAS REPORTED BY CUSTOMER THAT WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES, FIVE (5) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392330 ↗
• MalfunctionApr 9, 2026Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARIN (NH) 158 USP UNITS BLOOD COLLECTION TUBES, THE TUBE WAS BROKEN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835149 ↗
• MalfunctionNov 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, OCCASIONALLY INCORRECT TUBES WERE USED TO COLLECT A SAMPLE DUE TO SIMILARITIES IN THE CAP COLOR OF THE TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658290 ↗
• MalfunctionAug 6, 2025Leak/Splash; Premature Separation; Leak/Splash; Premature Separation

  IT WAS REPORTED AFTER USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, THERE WAS STOPPER POP OFF SEEN IN ONE (1) TUBE. THE SAMPLE WAS RECOLLECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730391 ↗
• MalfunctionJul 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, ONE (1) SHELF PACK WAS MISSING A LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413572 ↗
• MalfunctionJun 18, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, THIRTY (30) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283318 ↗
• MalfunctionJun 5, 2025Difficult to Insert; Difficult to Insert

  PATIENT 2 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, THE STOPPER WAS DIFFICULT TO PIERCE IN 3 TUBES. THE SAMPLES WERE RECOLLECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150242 ↗
• MalfunctionJun 5, 2025Difficult to Insert; Difficult to Insert

  PATIENT 3 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, THE STOPPER WAS DIFFICULT TO PIERCE IN 8 TUBES. THE SAMPLES WERE RECOLLECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150230 ↗
• MalfunctionJun 5, 2025Difficult to Insert; Difficult to Insert

  PATIENT 1 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES, THE STOPPER WAS DIFFICULT TO PIERCE IN 3 TUBES. THE SAMPLES WERE RECOLLECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150165 ↗
• MalfunctionOct 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES THERE WAS A FOREIGN SUBSTANCE INSIDE THE TUBE. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20374338 ↗
• MalfunctionOct 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES, TWO (2) TUBES HAD BEEN CONTAMINATED WITH A FOREIGN SUBSTANCE INSIDE THE TUBES. SAMPLE RECOLLECTION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370923 ↗
• MalfunctionAug 6, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT 3 BD VACUTAINER® SODIUM "HEPARIN" (NH) BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL. THE PATIENT WAS REDRAWN AND NO OTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921093 ↗
• MalfunctionMay 13, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) 158 USP UNITS BLOOD COLLECTION TUBES HAD INSUFFICIENT VACUUM FORCE. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299352 ↗
• MalfunctionApr 30, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES TEN (10) BLOOD SAMPLES WERE COAGULATED DURING TRANSPORT. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212135 ↗
• MalfunctionApr 12, 2024Material Discolored; Material Discolored

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES THERE WAS A TUBE STOPPER WITH COLOR VARIATION. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097049 ↗
• MalfunctionFeb 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SODIUM HEPARIN (NH) 158 USP UNITS BLOOD COLLECTION TUBES THERE WAS LOW YIELD OF LYMPHOCYTES RECOVERED FROM THE PLASMA. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ISOLATE LYMPHOCYTES FROM THE BLOOD SAMPLE WHEN PERFORMING BERYLLIUM LYMPHOCYTE PROLIFERATION TEST AND WE ARE GETTING LOW LYMPHOCYTE YIELDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788879 ↗
• MalfunctionSep 11, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® SODIUM HEPARIN (NH) 158 USP UNITS BLOOD COLLECTION TUBES AN UNSPECIFIED AMOUNT OF THEM HAD VACUUM ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT EXHIBITS VACUUM ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725831 ↗
• MalfunctionMay 20, 2022Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES ARE CLOTTING BY THE TIME THEY ARE BEING PROCESSED BY THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458463 ↗
• MalfunctionMar 10, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUUM IS NOT AS STRONG AS OTHER TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725215 ↗
• MalfunctionOct 1, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED FIVE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: UNDER FILL VOLUME BLOOD WAS COLLECTED BY EVACUATE SYSTEM WITH FBN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562282 ↗
• MalfunctionAug 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER¿ SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THIS EVENT OCCURRED FOUR TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HELLO, WE EXPERIENCED WHOLE BLOOD LEAKING OUT OF PLASTIC SODIUM HEPARIN TUBES DURING AIR TRANSPORT. WHAT IS THE ISSUE YOU EXPERIENCED? 4 TUBES FROM THIS LOT WERE SHIPPED IN THE SAME SHIPMENT AND LEAKING OF BLOOD CONTENTS WAS SEEN AFTER AIR TRANSPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277422 ↗
• MalfunctionJul 2, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP 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: THERE IS A LAB AT WMU MED WHO IS HAVING ISSUES WITH THEIR BLOOD COLLECTION TUBES (# 367874) NOT FILLING UP TO THE PROPER LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111708 ↗
• MalfunctionOct 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ADDITIVE WAS ABNORMAL WITH A BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THE LAB TECH STATED THAT WHEN THEY ARE PROCESSING THEIR SAMPLES, THE TUBES ARE GEL LIKE AND HARD. ADDITIONALLY, ON 2020-10-02 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AFTER FURTHER INVESTIGATION INTO THE SITUATION, IT WAS DETERMINED THAT IT WAS SITE COLLECTION ERROR. THE BLOOD WAS DRAWN IN A SYRINGE AND WAS CLOTTING EVEN BEFORE THEY ATTEMPTED TO TRANSFER IT TO THE VACUTAINER TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708285 ↗
• MalfunctionSep 2, 2020Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE TUBES WERE DISCOVERED TO BE COLLAPSED WITH 800 BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COLLAPSED TUBES.

  Patient problems: No Patient Involvement

  MAUDE report 10482920 ↗
• MalfunctionAug 14, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE TUBES ARE UNDER FILLING WITH A BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE UNDER FILLING. CUSTOMER CALLED TO REPORT THAT THEY ARE HAVING ISSUES WITH THE SODIUM HEPARIN VACUTAINERS, SHE STATES THAT THEY ARE ONLY DRAWING TO ABOUT 5 - 7 ML'S. THIS HAS BEEN AN ONGOING ISSUE, SHE DOES HAVE SAMPLES TO RETURN. SHE STATED THAT THEY ARE TESTING FOR RESEARCH PURPOSES, AND THE TESTING THEY DO NEEDS A CERTAIN AMOUNT AND THE TUBES BLOOD VOLUME IS INSUFFICIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K252040, K944566. One submission often covers many models, so check the product and lot details in each record.

• Z-2307-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
• Z-2306-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036