BD Vacutainer® EST™ Blood Collection Tube 362725Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 30382903627258), received between Mar 1, 2018 and Sep 11, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739949 ↗
• MalfunctionJan 8, 2026Short Fill

  IT WAS REPORTED WHILE COLLECTING BLOOD USING BD VACUTAINER® EST¿ BLOOD COLLECTION TUBE, 1 PATIENT SAMPLE WAS UNDERFILLED AFTER CLOTTING QUICKLY DURING COLLECTION. THE SAMPLE WAS RECOLLECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24015254 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, SAMPLE LEAKAGE WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843052 ↗
• MalfunctionNov 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THERE WAS A TUBE IN THE SHELF PACK WITH THE INCORRECT CAP COLOR. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783878 ↗
• MalfunctionOct 28, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BEFORE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE WITH A DIFFERENT CAP COLOR WAS MIXED IN WITH THE REST OF THE SHELF PACK. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551007 ↗
• MalfunctionMay 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® EST¿ BLOOD COLLECTION TUBE AN UNSPECIFIED AMOUNT OF CAPS WERE NOT STAYING ON THE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273864 ↗
• MalfunctionSep 2, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE BEEN ALERTED BY SEVERAL DEPARTMENTS OF THE HOSPITAL CENTRE OF A LACK OF VACUUM FOR PURGE TUBES (REF (B)(4) OF BATCH 2056870."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351387 ↗
• MalfunctionDec 17, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED A CLOGGED/BLOCKED INSTRUMENTATION PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SPA III QUICK CONNECTOR TO THE FILTER WASTE FILTER IS CLOGGED BECAUSE OF THE STOPPER OF THE TUBES. THE BD SYSTEM SPA III HAS TO CONSTANTLY BE WORKED ON AND UNCLOGGED BY OUR TECHNICAL SERVICE BECAUSE THE QUICK CONNECTOR TO THE WASTE FILTER CLOGS UP BECAUSE OF THE STOPPER OF THE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027966 ↗
• MalfunctionJun 25, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FOR 5 TO 6 MONTHS, THE NURSE HAS BEEN HAVING TROUBLE TAKING BLOOD SAMPLES WITH THE PRODUCT BD VACUTAINER LUER-LOCK ACCESS DEVICE. THE SYSTEM IS CONNECTED TO THE CONNECTION SYSTEM, WHEN SETTING UP THE BLOOD COLLECTION TUBE (CLIPPING), THE BLOOD DOES NOT GO BACK INTO THE TUBE. IT IS NECESSARY TO CHANGE THE SAMPLING TUBE 3 TIMES OUT OF 4 FOR THE SAMPLING TO BE DONE AUTOMATICALLY. USING THE SAME DEVICE WITH A SYRINGE, THE SAME PROBLEMS ARE ENCOUNTERED. NURSES MUST GO THROUGH A BLOOD SAMPLE BY CHANGING THE SAMPLE TUBE (UNTIL IT WORKS) OR WITH A SYRINGE TO MAKE UP FOR THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071417 ↗
• MalfunctionDec 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES 42 TUBES HAVE CRACKED WHILE FREEZING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES CRACK WHEN FREEZING .-70 DEGREES C. OLD PROTOCOL THAT HAS BEEN WORKING FOR YEARS WITH OUR TUBES. UNTIL NOW 42 TUBES HAS CRACKED AND LEAKED THE PAST 3 MONTHS. SAME PROTOCOL AND SAME EQUIPMENT(FREEZERS ETC.) IS USED AS BEFORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10951079 ↗
• MalfunctionJun 18, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES CONTAINED A MIX OF PRODUCT TYPE IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED OUT OF 100 TUBES, 99 ARE RED AND ONE TUBE IS GREY.

  Patient problems: No Patient Involvement

  MAUDE report 10168758 ↗
• MalfunctionJun 11, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER USE THE CAPS WERE DISCOVERED TO BE DAMAGED WITH A BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED CUSTOMER RECEIVED DAMAGED CAPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142671 ↗
• MalfunctionJun 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER USE WAS DISCOVERED THAT THE LIDS ARE CRACKED AND DAMAGED WITH A BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS). IT WAS REPORTED CUSTOMER RECEIVED DAMAGED CAPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10139795 ↗
• MalfunctionApr 1, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT TUBES ARE UNDER FILLING DURING USE WITH A BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER THE PROCEDURE, MY COLLEAGUE DID NOT FILL IN ANY PLASMA IN THE TRANSPARENT AND YELLOW TUBES. I TRIED WITH A NEW YELLOW TUBE MYSELF AND ONLY FILLED IN A LITTLE PLASMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910316 ↗
• MalfunctionDec 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES CAP WAS THE WRONG COLOR. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRONG CAP COLOUR TO PRODUCT CODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9480925 ↗
• MalfunctionNov 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES STARTED TO CRACK FROM THE BOTTOM OF THE TUBE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8078514 ↗
• MalfunctionOct 2, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES HAD CRACKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7925946 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN THE STOPPER. 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 7593581 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES HAD FOREIGN MATERIAL IN THE CAP. 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 7592649 ↗
• MalfunctionMay 18, 2018Incorrect Measurement; Device Contamination with Chemical or Other Material; Incorrect Measurement; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES EXPERIENCED CORING. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527497 ↗
• MalfunctionMay 3, 2018Incorrect Measurement; Device Contamination with Chemical or Other Material; Incorrect Measurement; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES WERE CORING, NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483211 ↗
• MalfunctionMay 2, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBE CAP NOT CONFORMING THE STOPPER POPS OUT.

  Patient problems: No Information

  MAUDE report 7480651 ↗
• MalfunctionMar 1, 2018Filling Problem; Device Operates Differently Than Expected

  IT WAS REPORTED AND CONFIRMED THAT 2 BD VACUTAINER® EST¿ PLASTIC TUBES WITH HEMOGARD¿ CLOSURE HAD NO RESIDUAL VACUUM CAUSING ¿UNDER FILLING ISSUES¿. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308050 ↗