BD Vacutainer® 365044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50382903650441), received between Dec 1, 2017 and May 1, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K160657); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WERE HAVING ERRONEOUS RESULT, NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7475800 ↗
• MalfunctionDec 13, 2017Retraction Problem

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBE SOMETIMES CAUSED AN AEROSOL. WHEN DRAWING MULTIPLE TUBES SOMETIMES THE SLEEVE WOULD NOT RETURN BACK OVER THE NEEDLE CONSISTENTLY CAUSING BLOOD TO REMAIN ON THE NEEDLE AND SLEEVE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7114766 ↗
• MalfunctionDec 7, 2017Fluid/Blood Leak; Device Operates Differently Than Expected

  IT WAS REPORTED THAT SOMETIMES THE GREEN BD VACUTAINER® BARRICOR¿ PLASMA BLOOD COLLECTION TUBES HAS BLOOD SQUIRT OUT OF THEM WHEN THE TUBE IS PULLED AWAY AFTER FILLING IT. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7097897 ↗
• MalfunctionDec 3, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT BLOOD POOLED IN THE STOPPER OF THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7077974 ↗
• MalfunctionDec 1, 2017Reflux within Device

  IT WAS REPORTED THAT DIFFERENT LOT NUMBERS OF THE BD VACUTAINER® BARRICOR¿ PLASMA BLOOD COLLECTION TUBE HAVE BEEN TESTED , AND AGAIN SEEING BLOOD POOLING IN THE STOPPER CAP, THOUGH NOT AS MUCH OR AS OFTEN AS THE PREVIOUS LOT NUMBER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7077152 ↗
• MalfunctionDec 1, 2017Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THAT THE BD VACUTAINER® BARRICOR¿ PLASMA BLOOD COLLECTION TUBE HAS BLOOD POOLS IN THE CAP AND THE BLOOD WILL SPILL OUT OF IT OFTEN TIMES LANDING ON OUR PANTS, SHIRTS, OR OTHER PLACES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7077085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160657. One submission often covers many models, so check the product and lot details in each record.

• Z-1142-2018 · Mar 22, 2018 · Terminated
  BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50
• Z-1180-2018 · Sep 18, 2017 · Terminated
  BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, proc