BD Vacutainer® 365043Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50382903650434), received between May 1, 2018 and May 14, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 18, 2017Terminated

   Increased amount of residual blood present on the top of stopper well after venipuncture

   Z-1180-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WERE BEING PUSHED BACK FROM THE DEVICE AND HAD TO BE HELD IN PLACE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7512983 ↗
• MalfunctionMay 10, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WERE FILLING SLOWLY.

  Patient problems: No Information

  MAUDE report 7503051 ↗
• MalfunctionMay 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER BARRICOR LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES HAD ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481942 ↗
• MalfunctionMay 1, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WERE UNDERFILLING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7477396 ↗
• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES "BARRICOR - 365043 - STABILITY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7476327 ↗

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