BD Vacutainer® ACD Solution B Blood Collection Tubes 364816Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30382903648161), received between Apr 11, 2018 and Feb 1, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES, CELLS BEGUN TO LYSE AND HEMOLYZE UPON COLLECTION IN APPROXIMATELY SEVEN HUNDRED (700) TUBES. AS THE SAMPLES COLLECTED WERE FOR RESEARCH PURPOSES, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623361 ↗
• MalfunctionApr 14, 2022Defective Component; Defective Component

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED A BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONE OF THE TUBES FROM THE SHELF PACK HAS THE CAP DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115465 ↗
• MalfunctionApr 13, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 364816, BATCH NO. 0009484 AND 0227127. IT IS REPORTED CUSTOMER EXPERIENCED UNDER FILLING. VERBIAGE RECEIVED, - "EVENT DESCRIPTION: WHILE DRAWING LABS ON A PATIENT THE BLOOD STOP FLOWING. AFTER TRYING SEVERAL OF THE SAME TYPE OF VACUTAINERS ONE FINALLY WORKED. IT WAS IDENTIFIED THAT THE VACUTAINERS HAD NO VACUUM IN THEM"".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657847 ↗
• MalfunctionMar 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "WHEN OPENING THE PACK THE TUBE WAS FOUND WITH A FOREIGN SEDIMENT IN THE BOTTOM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441221 ↗
• MalfunctionJul 15, 2020Break; Break

  IT WAS REPORTED THAT THE BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBE BROKE IN THE CENTRIFUGE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE ALSO STATED THAT THEIR CUSTOMER REPORTED THAT YELLOW TUBES WERE BREAKING OFF IN CENTRIFUGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279223 ↗
• MalfunctionJul 15, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 4 BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD POOR VACUUM AND UNDERFILLED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED A CALL FROM THE DISTRIBUTOR STATING THAT AT FOUR TUBES WILL NOT SUCTION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279178 ↗
• MalfunctionJul 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES STOPPER PULLS OUT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364816, BATCH NO. 9126927. IT WAS REPORTED THAT THE 2ND STOPPER PULLOUT FORCE DID NOT MEET OUR SPECIFICATION. DURING R&D TESTING IN (B)(4), WE IDENTIFIED AN INSTANCE WHERE THE 2ND STOPPER PULLOUT FORCE DID NOT MEET OUR SPECIFICATION. TEST PRODUCT: CATALOG # 364816, BATCH 9126927. TEST DATE: (B)(6) 2019. DATA REVIEW DATE: JULY 9, 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843428 ↗
• MalfunctionAug 13, 2018Break; Break

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER ACD SOLUTION B BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH BREAKAGE WHILE SPINNING TUBES. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777355 ↗
• MalfunctionAug 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD ISSUES WITH HEMOLYSIS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776789 ↗
• MalfunctionJun 19, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES MAY HAVE BEEN STORED AT THE WRONG TEMPERATURE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615236 ↗
• MalfunctionJun 13, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES WERE ONLY FILLING TO 1ML. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597470 ↗
• MalfunctionJun 13, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD NO SUCTION. 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 7597156 ↗
• MalfunctionJun 5, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD A DIRTY STOPPER. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571830 ↗
• MalfunctionMay 23, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD "FOREIGN MATTER".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7536822 ↗
• MalfunctionMay 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD LARGE FOREIGN MATERIAL IN IT. 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 7525824 ↗
• MalfunctionMay 9, 2018Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD "FM AND BROKEN TUBES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500184 ↗
• MalfunctionApr 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAS MOLDING DEFECTS BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424154 ↗