BD Vacutainer® Serum Blood Collection Tubes 368660Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 30382903686606), received between Nov 7, 2017 and Oct 22, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (BK050036, K960250); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS HAIR ON THE TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 10718614 ↗
• MalfunctionOct 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS DISCOVERED IN TUBE PRIOR TO USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS HAIR ON THE TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 10718612 ↗
• MalfunctionOct 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THERE IS A PARTICULATE ON THE TUBE."

  Patient problems: No Patient Involvement

  MAUDE report 10715217 ↗
• MalfunctionMar 24, 2020Leak/Splash; Short Fill; Volume Accuracy Problem; Leak/Splash; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED DURING USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAD A CRACK IN THE TUBE IN THE AREA WHERE THE STOPPER IS. THE TUBE HAD A LOW DRAW VOLUME, LIKELY BECAUSE OF THE TUBE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9872269 ↗
• MalfunctionMar 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS AND INCORRECT ADDITIVE WERE FOUND AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, (B)(6) 2020: RECEIVED PHONE CALL. SHE DOES NOT WANT TO FILE A COMPLAINT. SHE WOULD LIKE TO KNOW WHAT ADDITIVE IS THIS CLOT ACTIVATOR AS THEIR REFERENCE LAB REJECTED SPECIMEN DUE TO CLOT ACTIVATOR IN VACUTAINER. TUBE WAS SENT OFF TO TEST MICROALBUMIN URINE BUT WAS REJECTED. NO OTHER INFORMATION IS AVAILABLE, NO SAMPLES AVAILABLE, NO ACK LETTER REQUIRED AND NO CLOSURE LETTER NEEDED. (B)(6) 2020: I EXPLAINED TO THE CUSTOMER THAT THE NURSES SHOULD NOT BE USING SERUM TUBES TO COLLECT URINE SPECIMENS. I SENT HER THE LINK TO THE IFU TO EXPLAIN THAT THE PLASTIC SERUM TUBES CONTAIN SILICONE AND MICRONIZED SILICA PARTICLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9849874 ↗
• MalfunctionMay 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS WATER CONDENSATION IN THE TUBES WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368660, BATCH NO. 8345630 AND 8215776. IT WAS REPORTED THERE IS WATER CONDENSATION IN THE TUBES. INFORMED CUSTOMER THAT THEY ARE MOST LIKELY SEEING THE CLOT ACTIVATOR THAT IS SPRAY COATED ON THE SIDE WALLS OF THE TUBE. IT APPEARS AS A DRIED WHITE FILM. SHE STATES THIS IS WHAT THEY ARE SEEING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654524 ↗
• MalfunctionJun 12, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WERE UNDERFILLING. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594347 ↗
• MalfunctionJun 11, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES UNDER FILLED. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589524 ↗
• MalfunctionJun 11, 2018Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD COLLAPSED TUBES CAUSED NO SERIOUS INJURY MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589005 ↗
• MalfunctionJun 11, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. IT WAS STATED ¿THE CUSTOMER REPORTED THAT THE TUBE LOOKS LIKE IT WAS WET INSIDE THAT THEN IT DRIED AND LEFT SPOTS ALL OVER THE TUBE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588326 ↗
• MalfunctionMay 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD INCORRECT COLOR.

  Patient problems: No Information

  MAUDE report 7506858 ↗
• MalfunctionApr 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7462404 ↗
• MalfunctionMar 26, 2018Break

  IT WAS REPORTED THAT A BD VACUTAINER¿ VENOUS BLOOD COLLECTION SERUM SILICONE-COATED PLASTIC TUBE WITH CONVENTIONAL STOPPER WAS FOUND BROKEN AT COLLECTION SITE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7369818 ↗
• MalfunctionNov 29, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONE RED BD VACUTAINER® SERUM TUBE IN THE BOX DID NOT HAVE A LABEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068346 ↗
• MalfunctionNov 7, 2017Detachment Of Device Component; Device Operates Differently Than Expected

  IT WAS REPORTED THAT FOR THE 13 X 100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC TUBE SERUM TUBE, THE STOPPER WAS MORE DIFFICULT TO PIERCE AND THIS LED TO STOPPER PULL OUT WHEN REMOVING COLLECTION DEVICE. NO SERIOUS INJURY, AND NO MEDICAL INTERVENTION. NO MUCOUS MEMBRANE EXPOSURE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK050036, K960250. One submission often covers many models, so check the product and lot details in each record.

• Z-1618-2022 · May 25, 2022 · Open, Classified
  a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/
• Z-0968-2018 · Aug 29, 2017 · Terminated
  BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing an
• Z-2434-2015 · Jun 23, 2015 · Terminated
  BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
• Z-2631-2014 · Jun 23, 2014 · Terminated
  BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens
• Z-2629-2014 · Jun 23, 2014 · Terminated
  BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood spec
• Z-0052-05 · Aug 20, 2004 · Terminated
  BD Vactuainer SST glass and plastic tubes.