BD Vacutainer® Sodium HeparinN (NH) 33 USP = 33 IU Blood Collection Tubes 367671Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 30382903676713), received between May 8, 2018 and Feb 2, 2022 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Short Fill” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ABNORMAL ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER CALLED TO ASK IF THE TUBES THEY HAVE OF SODIUM HEPARIN GLASS ARE OKAY TO USE BECAUSE THE ADDITIVE IS PULLED AT THE BOTTOM, SORTA FLAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424660 ↗
• MalfunctionJul 17, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING / MICRO CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I RECEIVED A CALL FROM A CUSTOMER CALLING FROM LAB CORP IN GENEVA, SWITZERLAND. SHE STATED THAT ONE OF THE STUDIES THEY¿RE RUNNING THEY ARE SEEING REALLY HIGH CLOTTING RATES IN PARTICULAR FOR SODIUM HEPARIN TUBES. 13 SAMPLES WERE AFFECTED BETWEEN EARLY APRIL TO JUNE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186230 ↗
• MalfunctionMar 30, 2020Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE GLASS TUBE HAD DIAMETER OF 12.7MM INSTEAD OF 12MM WITH A BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A GLASS TUBE APPEARED TO BE OUT OF SPEC DIMENSIONALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9897564 ↗
• MalfunctionFeb 6, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT (B)(4) BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD CLOTTING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COVANCE IS EXPERIENCING CLOTTING ISSUES. COVANCE EXPERIENCED CLOTTING ISSUES ON 65 SAMPLES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677476 ↗
• MalfunctionDec 6, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBE EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367671; BATCH NO. 9095735. COMPLAINT 2 OF 2: IT WAS REPORTED THAT STOPPERS HAVE BEEN COMING OFF OF TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9427291 ↗
• MalfunctionNov 21, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 367671; BATCH NO. 9095735. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES THE STOPPERS HAVE BEEN COMING OFF OF TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS AN ISSUES WITH THE LIDS COMING OFF TUBES CAUSING THE LOSS OF SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355216 ↗
• MalfunctionSep 9, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBE EXPERIENCED LOW DRAW/UNDERFILL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367671. BATCH NO: 8249503. IT WAS REPORTED THAT THERE IS UNDERFILL; THEY ARE 2 ML TUBES SO SHOULD PULL 2 ML BUT PULL BETWEEN 1.2-1.5 ML. ALLEGATION: CUSTOMER REPORTED THEY ARE 2 ML TUBES SO SHOULD PULL 2 ML BUT THEY PULL BETWEEN 1.2 TO 1.5 ML.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8975086 ↗
• MalfunctionJul 1, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES STOPPER PULLED OUT. THIS OCCURRED ON 107 OCCASIONS AND WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367671 BATCH NO: 9095733, 9095734, 9095735 IT WAS REPORTED THAT DURING R&D TESTING IN FRANKLIN LAKES, INSTANCES WERE IDENTIFIED WHERE THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATION. THE MEAN FORCE WAS BELOW SPECIFICATION DURING R&D TESTING IN FRANKLIN LAKES, WE HAVE IDENTIFIED INSTANCES WHERE THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATION. (THE 2ND PULLOUT FORCE IS THE FORCE TO REMOVE THE STOPPER AFTER IT HAS BEEN REMOVED AND REINSERTED INTO THE FILLED TUBE.) THE SPECIFIC PRODUCT SKU AND BATCH NUMBERS WHERE THIS OCCURRED ARE LISTED BELOW. AS THE TEST REQUESTOR I REVIEW THE DATA TO MAKE THE ASSESSMENT REGARDING THE PASSING OR FAILING OF THE TEST DATA SO THE AWARENESS DATES BELOW REFLECT MY REVIEW OF THE DATA SHEETS AND IDENTIFICATION OF FAILING RESULTS. (B)(6) 2019 (B)(6) 2019 367671 9095733 MEAN FORCE BELOW SPECIFICATION (B)(6) 2019 (B)(6) 2019 367671 9095734 MEAN FORCE BELOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750165 ↗
• MalfunctionJun 14, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 37 BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES FROM LOT # 9095733, 31 TUBES FROM LOT # 9095734, AND 34 TUBES FROM LOT # 9095735 HAD ISSUES OF LOOSE STOPPER CLOSURE FOUND DURING RESEARCH AND DEVELOPMENT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D PRODUCT TESTING, WE SAW INCIDENTS OF STOPPER/SHIELD SEPARATION WITH THE FOLLOWING BATCHES OF CATALOG NUMBER 367671: 9095733 - 37 OUT OF 40 AFFECTED, 9095734 - 31 OUT OF 40 AFFECTED AND 9095735 - 34 OUT OF 4O AFFECTED. ADDITIONAL INFORMATION STATES, "I SPOKE FURTHER WITH THE TEST TECH THIS MORNING TO CLARIFY HER OBSERVATIONS. SHE INDICATED THAT THE STOPPER MOVED WITHIN THE SHIELD MORE THAN SHE HAS TYPICALLY OBSERVED, BUT THAT NONE OF THE STOPPERS AND SHIELDS SEPARATED COMPLETELY WHEN REMOVED FROM THE TUBE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701415 ↗
• MalfunctionNov 16, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM "HEPARIN" (NH) BLOOD COLLECTION TUBES THE GEL WAS NOT SEPARATING PROPERLY. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8078500 ↗
• MalfunctionSep 19, 2018Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD VACUTAINER SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES WERE UNDERFILLING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890190 ↗
• MalfunctionJun 11, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES COMPLAINT FROM ONE OF THE SITES SAYING THAT THEY HAVE HAD CLOTTED SAMPLES. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588711 ↗
• MalfunctionJun 11, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES WERE NOT FILLING CORRECTLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586637 ↗
• MalfunctionJun 11, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARIN N (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD UNDERFILL. NO SERIOUS INJURY MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586274 ↗
• MalfunctionJun 8, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD A "LABEL ISSUE" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7584034 ↗
• MalfunctionJun 6, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES WERE CLOTTING. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575945 ↗
• MalfunctionJun 4, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BLOOD SPECIMEN COLLECTION DEVICE HAD CLOTTING.

  Patient problems: No Information

  MAUDE report 7565922 ↗
• MalfunctionJun 4, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES EXHIBITED CLOTTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565861 ↗
• MalfunctionMay 31, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD LOW DRAW/VACUUM. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558471 ↗
• MalfunctionMay 29, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARIN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD UNDER FILING. NO SERIOUS INJURY MEDICAL INTERVENTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549703 ↗
• MalfunctionMay 25, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES UNDER FILLED.

  Patient problems: No Information

  MAUDE report 7544537 ↗
• MalfunctionMay 24, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES WERE UNDERFILLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542941 ↗
• MalfunctionMay 17, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) 33 USP: 33 IU BLOOD COLLECTION TUBES UNDER FILLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522980 ↗
• MalfunctionMay 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN THEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518698 ↗
• MalfunctionMay 9, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARIN (NH) 33 USP: 33 IU BLOOD COLLECTION TUBES WERE CLOTTING.

  Patient problems: No Information

  MAUDE report 7500096 ↗

Recalls under the same FDA submission

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

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