BD Vacutainer® 365047Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 50382903650472), received between Apr 30, 2018 and May 14, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE TUBE, ALONG WITH ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT CUSTOMER REPORTS TRACE-ELEMENT CONTAMINATION FROM SERUM COLLECTION TUBES 367983 AND 365047. "THE ISSUE WAS REPORTED BY KEY-YOUNG CHOE IN A 2021 PAPER IN THE JOURNAL OF TRACE ELEMENTS IN MEDICINE AND BIOLOGY TITLED "EVALUATION OF TRACE-ELEMENT CONTAMINATION FROM SERUM COLLECTION TUBES USED BY THE CALIFORNIA BIOBANK PROGRAM." THE AUTHORS PERFORMED LEACHING TESTS FOR SSTS WITH DI WATER THAT REVEALED DETECTABLE LEVELS OF CR, MN, CO, SR, SB, PB, AND U WERE MEASURED, WHILE SB WAS ELEVATED. TESTS OF PSTS ALSO REVEALED CONTAMINATION OF MN, CO, SR, AND SB, WITH CO AND SR BEING MUCH HIGHER THAN THOSE FOUND FROM SSTS. TRACE-ELEMENT MEASUREMENTS FROM 200 SAMPLES ARCHIVED BY THE CALIFORNIA BIOBANK PROGRAM USING SSTS SUGGEST THAT SST CONTAMINATION WAS NEGLIGIBLE FOR SE AND MO. FOR MN, AS, SR, CD, AND HG, BASED ON THEIR LEACHING RESULTS, ONLY A FRACTION OF THESE SAMPLES HAD CONSIDERABLY HIGH CONCENTRATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402951 ↗
• MalfunctionJun 6, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBES HAD "HEMOLYSIS" 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 7574608 ↗
• MalfunctionJun 4, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBES HAD "INCORRECT RESULTS" 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 7566848 ↗
• MalfunctionMay 3, 2018Volume Accuracy Problem; Volume Accuracy Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484890 ↗
• MalfunctionMay 3, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES HAD POOR SEPARATOR MOVEMENT.

  Patient problems: No Information

  MAUDE report 7484617 ↗
• MalfunctionMay 3, 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 7484445 ↗
• MalfunctionMay 2, 2018Short Fill; Short Fill

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

  Patient problems: No Information

  MAUDE report 7481672 ↗
• 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 HAD "SEPARATOR POSITION".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7475734 ↗
• MalfunctionApr 30, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES "BARRICOR - 365047 - UNDERFILLING".

  Patient problems: No Information

  MAUDE report 7472569 ↗

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