BD Vacutainer® ESR Blood Collection Tubes 369741Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 30382903697411), received between Dec 6, 2017 and Aug 15, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Short Fill” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Crack; Crack

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES CUSTOMER FOUND THE TUBES BROKEN/CRACKED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEFECT: FOUND THAT THE WALL OF THE BLOOD COLLECTION TUBE WAS BROKEN. QUANTITY: 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553700 ↗
• MalfunctionAug 15, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ESR BLOOD COLLECTION TUBES THE GLASS TUBE BROKE AND LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: STAGE: DURING BLOOD COLLECTION. DEFECT: BROKEN BLOOD COLLECTION TUBE. QUANTITY: 1 TUBE. IMPACT: CAUSED A BLOOD LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551053 ↗
• MalfunctionMay 8, 2023Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ESR BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT AFFECTED 200 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "INSUFFICIENT NEGATIVE PRESSURE, I DID A PUMPING TEST, AND 1 OF THE 5 TUBES WAS OBVIOUSLY INSUFFICIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891134 ↗
• MalfunctionApr 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® ESR BLOOD COLLECTION TUBES "BLACK" FOREIGN MATTER WAS DISCOVERED IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PHASE: WHEN UNPACKING, DEFECT: FOREIGN BODY, QUANTITY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705376 ↗
• MalfunctionMar 27, 2023Crack; Crack

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ESR BLOOD COLLECTION TUBE THE TUBE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE BLOOD WAS DRAWN, THE ERYTHROCYTE SEDIMENTATION RATE TEST TUBE WAS FOUND TO BE CRACKED, AND THE LABORATORY SAID THAT IT COULD NOT BE TESTED, SO THE BLOOD WAS DRAWN AGAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625206 ↗
• MalfunctionMar 3, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ESR BLOOD COLLECTION TUBE THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE ADDRESS OF THE OUTER PACKAGING IS INCONSISTENT WITH THE ADDRESS OF THE TUBE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482100 ↗
• MalfunctionSep 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN BLOOD IS COLLECTED, THE NEEDLE OF BLOOD COLLECTION IS PIERCED INTO THE TUBE, AND THE BLOOD FLOWS OUT OF THE TUBE FROM THE EDGE OF THE BLACK LID, BUT DOES NOT ENTER THE TUBE, RESULTING IN A LARGE AMOUNT OF BLOOD ON THE HANDS OF THE STAFF, WHICH IS EASY TO CAUSE OCCUPATIONAL EXPOSURE OF THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420478 ↗
• MalfunctionMay 25, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 BD VACUTAINER® ESR BLOOD COLLECTION TUBES WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE TUBES DID NOT FILL COMPLETELY. VERBIAGE RECEIVED: CUSTOMER IS "HAVING A PROBLEM WITH THE TUBES COMING BACK ON A CERTAIN LOT ALL UNDERFILLED. NEEDS TO KNOW IF THEY NEED TO BE REJECTED OR IF THEY¿RE ABLE TO USE THE SAMPLES." CUSTOMER NOTICED THIS ISSUE TODAY ON 8-10 TUBES FOR LOT # 0258369. SAMPLES HAVE A STABILITY OF FOUR HOURS AND CUSTOMER IS REQUESTING A CALL BACK AS SOON AS POSSIBLE AS WELL AS THE PRODUCT INSERT FOR WORKFLOW PURPOSES. WO NOTES: CUSTOMER STATES THAT THEY ARE ALSO SEEING UNDERFILLING WITH LOT#0167265. CUSTOMER HAS TAKEN TUBES FROM BOTH LOTS AND TRIED FILLING FROM SYRINGE AND THEY DO NOT DRAW TO THE FILL LINE. TOLD CUSTOMER THAT IF THEY ARE USING WING SET AND THIS IS FIRST TUBE DRAWN THAT THEY WILL SHORT DRAW AND THEY SHOULD MAKE SURE THAT THE TUBES ARE NOT PUSHING BACK FROM THE HOLDER. SHE STATES THAT THEY ARE NOT PUSHING BACK FROM HOLDER. DISCUSSED THAT IF TUBES ARE NOT FILLED TO STATED DRAW VOLUME THAT THE BLOOD/ADDITIVE RATIO MAY NOT BE CORRECT. SHE ASKED FOR IFU FOR THIS TUBE. EMAILED LINK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880971 ↗
• MalfunctionDec 14, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE HAD NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN USING THE TUBE, IT WAS FOUND THAT THE TUBE HAS NO LABEL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11006048 ↗
• MalfunctionApr 21, 2020Short Fill; Volume Accuracy Problem; Device Markings/Labelling Problem; Short Fill; Volume Accuracy Problem; Device Markings/Labelling Problem

  IT WAS REPORTED DURING USE THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES HAD UNDER FILL OR LOW DRAW OF A TUBE WITH BLOOD AND INCORRECT FILL LINE POSITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING USE, IT WAS FOUND THAT INDICATION SCALE IS NOT CLEAR, NEGATIVE PRESSURE CAPACITY IS DIFFERENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9982571 ↗
• MalfunctionJan 29, 2020Short Fill; Short Fill

  IT WAS REPORTED THAT TUBES ARE UNDER FILLING WITH A BD VACUTAINER® ESR BLOOD COLLECTION TUBES. THIS OCCURRED ON 4 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBES DID NOT FILL COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9643280 ↗
• MalfunctionNov 14, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES HAD AN ISSUE WITH LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USE, THE CUSTOMER FOUND 1EA TUBE HAS LOW DRAW ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9321535 ↗
• MalfunctionOct 4, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USE, THE CUSTOMER FOUND 1EA TUBE HAS LOW DRAW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9156289 ↗
• MalfunctionJul 31, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE THERE WAS A LOW DRAW WITH A BD VACUTAINER® ESR BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE, THE CUSTOMER FOUND 1EA TUBE HAS NO DRAW ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846781 ↗
• MalfunctionJul 11, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH BD VACUTAINER® ESR BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RECEIVED CALL, SHE STATED 5 TUBES WERE UNDER FILLING. (B)(6) 2019- SPOKE TO THE CUSTOMER DIRECTLY. SHE RECEIVED THE PRODUCT RETURN NOTIFICATION AND WILL SEND IN THE TUBES. SHE IS INTERESTED IN THE INVESTIGATION FINDINGS, PARTICULARLY IF THE TUBES FILL COMPLETELY CLOSER TO SEA LEVEL. SHE THINKS THAT THE HIGH ALTITUDE MAY CONTRIBUTE TO THE SHORT FILL. THEY ORDER THE COAGULATION TUBES FOR HIGH ALTITUDE. SHE HAD NO OTHER QUESTIONS." 5 OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781265 ↗
• MalfunctionJul 2, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED DURING USE THERE WAS BLOOD LEAKING AT THE STOPPER WITH A BD VACUTAINER® ESR BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USE, THE CUSTOMER FOUND 1EA LEAK BLOOD AT THE STOPPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8753931 ↗
• MalfunctionMay 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® ESR BLOOD COLLECTION TUBE WAS CRACKED AND BLOOD LEAKED FROM THE TUBE WALL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER FEEDBACK BEFORE WITHDRAW THE BLOOD, TUBE WITH NO DEFECT VIA EYE INSPECT, DURING WITHDRAW THE BLOOD, BLOOD LEAKED OUT FROM THE TUBE WALL. NO BLOOD LEAKED ON TO THE NAKED SKIN. 1 EA OCCURRED SUCH ISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596477 ↗
• MalfunctionMay 2, 2019Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES BLOOD LEAKED FROM THE TUBE WALL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: CUSTOMER FEEDBACK DURING WITHDRAW THE BLOOD FROM PATIENT, BLOOD LEAKAGE FROM THE TUBE WALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575369 ↗
• MalfunctionApr 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES PATIENT'S BLOOD LEAKAGE FROM THE TUBE WALL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: CUSTOMER REPORT DURING WITHDRAW THE BLOOD FROM PATIENT, PATIENT'S BLOOD LEAKAGE FROM THE TUBE WALL. NURSE THEN CHANGED A NEW TUBE. NO BLOOD EXPOSURE ON NAKED SKIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8560434 ↗
• MalfunctionMay 8, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® ESR BLOOD COLLECTION TUBES UNDER FILLED.

  Patient problems: No Information

  MAUDE report 7496882 ↗
• MalfunctionDec 14, 2017Misassembled

  IT WAS REPORTED THAT A RUBBER STOPPER OF THE BD VACUTAINER® GLASS WESTERGREN BLOOD SEDIMENTATION RATE DETERMINATION TUBES WAS ASSEMBLED IN THE WRONG DIRECTION. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119692 ↗
• MalfunctionDec 6, 2017Burst Container or Vessel

  IT WAS REPORTED THAT GLASS, PAPER LABEL, 13X75 MM, 2.4 ML BD VACUTAINER® WESTERNGREN SEDIMENTATION RATE DETERMINATION, BUFFERED CITRATE (32.0 MG SODIUM CITRATE 4.2 MG CITRIC ACID/ML) 0.6 ML, BLACK BD HEMOGARD¿ BURST DURING LABELING. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089139 ↗