BD Vacutainer® FX 10mg 8mg Blood Collection Tubes 368587Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903685876), received between Aug 23, 2019 and Dec 27, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Short Fill” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K901449); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBE EXPERIENCED DIFFICULTY MOVING THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368587, BATCH NO. 9095806. IT WAS REPORTED THAT A SAMPLE HAD FAILED THE SECOND STOPPER PULLOUT TEST. I¿VE BEEN MANAGING SOME PRODUCT TESTING AND DISCOVERED A SAMPLE THAT HAD FAILED THE SECOND STOPPER PULLOUT TEST. THE SAMPLES ARE REQUIRED TO RECORD A 2ND STOPPER PULLOUT FORCE OF ABOVE 0.7LB, BUT THIS SAMPLE ONLY RECORDED A PULLOUT FORCE OF 0.155LB. TUBE TYPE: SODIUM FLUORIDE 13X75MM, 4ML DRAW VOLUME CATALOG NUMBER: 368587 AND LOT NUMBER: 9095806.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527829 ↗
• MalfunctionAug 28, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH A BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "TUBE EXPERIENCED UNDER FILLING DURING USE." CAT# 368587 AND LOT# 9065849; 29-JUL-2019, 7-AUG-2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8940436 ↗
• MalfunctionAug 23, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) TUBES HAD LOW DRAW. THIS OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 368587. BATCH/LOT: 8345628. IT WAS REPORTED THAT "WHEN THEY SLID THE TUBES ONTO THE NEEDLE HOLDERS IT ACTED LIKE THEY WERE NOT IN A GOOD VEIN. GROUP WAS HAVING ISSUES WITH SOME OF THE T03 TUBES. WHEN THEY SLID THE TUBES ONTO THE NEEDLE HOLDERS IT ACTED LIKE THEY WERE NOT IN A GOOD VEIN. THE PROBLEM WITH THAT IS THEY HAD ALREADY DRAWN BLOOD TUBES BEFORE AND AFTER THEY TRIED WITH THE GRAY TUBES AND THEY DIDN¿T HAVE TO MOVE THE NEEDLE AT ALL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926868 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901449. One submission often covers many models, so check the product and lot details in each record.

• Z-2297-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
• Z-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
• Z-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664