BD Vacutainer® Blood Alcohol Determinations Tube 367001Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 30382903670018), received between Apr 24, 2018 and Dec 30, 2025 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (13 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 15, 2022Class IIOpen, Classified

   The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.

   Z-0095-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

2. May 30, 2019Class IITerminated

   Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)

   Z-2279-2019 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS TUBE THAT BLOOD WAS CLOTTING AND SEPARATING IN 48 TUBES. TUBES WERE EXPIRED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929134 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE CRACKING AFTER BEING FROZEN AT -20C. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457207 ↗
• MalfunctionOct 17, 2025Crack; Excessive Cooling; Crack; Excessive Cooling

  IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS TUBE, AN UNSPECIFIED NUMBER OF TUBES WERE STORED IN A FREEZER AT TEMPERATURES BELOW -20°C AND ARE BREAKING UNDER FREEZING CONDITIONS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328404 ↗
• MalfunctionApr 30, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING USE WITH 28 BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG THE TUBES CRACKED/BROKE WHILE IN THE FREEZER. SAMPLES WERE FROM POST-MORTEM PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT 28 OUT OF LAST 32 SPECIMENS HAVE BROKEN WHILE IN THE -30C FREEZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841508 ↗
• MalfunctionApr 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FLUORIDE TUBES THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT AFFECTED 1500 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLACK PARTICLES NOTICED ON/IN TUBES. BLACK PARTICLE ON/IN VIALS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751033 ↗
• MalfunctionApr 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG HAD "BLACK" FOREIGN MATTER IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS SEEING BLACK PARTICLES IN BD 367001 ,LOT #321350.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714772 ↗
• MalfunctionApr 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG "BLACK" FOREIGN MATTER WERE DISCOVERED IN TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES TUBES CONTAIN BLACK PARTICLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705358 ↗
• MalfunctionAug 18, 2022Crack; Crack

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG TUBES ARE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THEY ARE RECEIVING TUBES WITH HAIR LINE CRACKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255467 ↗
• MalfunctionAug 4, 2022Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES LOST VACUUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUTOMER MENTIONED THAT THE PHLEBOTOMISTS HAD SOME TUBES THAT LOST VACUUM, BUT SHE DID NOT USE THESE WHEN DRAWING THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171829 ↗
• MalfunctionJul 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG, SAMPLE WITH EXTREMELY HIGH ALCOHOL CONCENTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGING A QUALITY ISSUE THAT HAS ARISEN WITH SOME RECENTLY MANUFACTURED BD VIALS, POTENTIALLY, AND WONDERING IF YOU COULD SHARE WHAT YOU HAVE LEARNED ABOUT THEIR MANUFACTURING CONCERNS. TWO SAMPLES COME BACK WITH EXTREMELY HIGH, NOT LIKELY TO BE SEEN IN A LIVING PERSON, ALCOHOL CONCENTRATIONS. CUSTOMER INQUIRING IF THEY HAD A QC ISSUE OR CHANGED VOLATILES THAT THEY WERE USING IN THEIR PROCESS THAT COULD BE OFF-GASSING. THE 2 ERRONEOUS ALCOHOL RESULTS WERE DRAWN BY THE SAME PHLEBOTOMIST ON 2 SEPARATE INDIVIDUALS 2 WEEKS APART. BOTH HAD THE SAME EXTREMELY HIGH BLOOD ALCOHOL RESULT OF 1.0%, WHICH SHE STATED IN HER EMAIL, "NOT LIKELY TO BE SEEN IN A LIVING PERSON." THE SECOND INDIVIDUAL HAD BREATH TEST RESULT OF 0.20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070772 ↗
• MalfunctionJul 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG, SAMPLE WITH EXTREMELY HIGH ALCOHOL CONCENTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGING A QUALITY ISSUE THAT HAS ARISEN WITH SOME RECENTLY MANUFACTURED BD VIALS, POTENTIALLY, AND WONDERING IF YOU COULD SHARE WHAT YOU HAVE LEARNED ABOUT THEIR MANUFACTURING CONCERNS. TWO SAMPLES COME BACK WITH EXTREMELY HIGH, NOT LIKELY TO BE SEEN IN A LIVING PERSON, ALCOHOL CONCENTRATIONS. CUSTOMER INQUIRING IF THEY HAD A QC ISSUE OR CHANGED VOLATILES THAT THEY WERE USING IN THEIR PROCESS THAT COULD BE OFF-GASSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070733 ↗
• MalfunctionNov 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 7 BD VACUTAINERS® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD VACUTAINER® FLUORIDE TUBES OUTGASSED ISOBUTYLENE THAT COULD BE MIS-IDENTIFIED AS METHANOL WHEN A SINGLE-COLUMN GAS CHROMATOGRAPHIC SYSTEM IS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866296 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE HAD DISCOLORED ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367001, BATCH NO. 0345747. IT WAS REPORTED THAT THE ADDITIVE IN THE TUBES IS CAKED ON THE SIDES. PER EMAIL: HI, OUR EDMONTON WAREHOUSE RECEIVED : ¿ 5CS OF 367001 LOT 0345747 ON PO 4512336235. ¿ 1CS OF 367001 LOT 0345747 ON PO 4512352818. ¿ 1CS OF 367001 LOT 0345747 ON PO 4512434764. ¿ 3CS OF 367001 LOT 0345747 ON PO 4512473616. THEY ARE GUESSING THESE ARE THE SALTS THEY SEE ON THE SIDE OF THE TUBES AND STUCK TO THE CAPS. THEY HAVE NOT SEEN POWDER CAKED ON THE SIDES OF ANY OF THESE BD TUBES BEFORE. THE SEALS ARE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637917 ↗
• MalfunctionSep 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100 MG POTASSIUM OXALATE: 20 MG AN UNKNOWN VOLATILE WAS FOUND TO BE OFF-GASSING INTO SAMPLE BY LABORATORY PERSONNEL. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN UNKNOWN AND UNEXPECTED VOLATILE WAS FOUND TO BE OFF-GASSING INTO OUR FORENSIC BLOOD ALCOHOL SAMPLES. I ACTUALLY IDENTIFIED TWO SOURCES, PTFE/BUTYL CRIMP CAP SEPTA OF THE PERKIN ELMER GAS CHROMATOGRAPH VIALS USED FOR ANALYSIS AND ALSO BD GREY TOP STOPPERS OF 10 ML 100 MG SODIUM FLUORIDE/20 MG POTASSIUM OXALATE VACUTAINERS (CATALOG NUMBER 367001). THE VOLATILE WAS RECENTLY IDENTIFIED BY HS-GC-MS AS 2-BUTENE AT ANOTHER LABORATORY FOR US. THE APPEARANCE OF THIS UNEXPECTED VOLATILE IS A RECENT PHENOMENON AND I SUSPECT SEVERAL MANUFACTURERS PURCHASE THE RAW RUBBER PRODUCT FOR THEIR APPLICATIONS FROM LIMITED SUPPLIERS. ALTHOUGH 2-BUTENE IS EASILY SEPARATED FROM OUR ANALYSIS OF INTEREST VIA ANALYSIS BY DUAL COLUMN HEADSPACE GAS CHROMATOGRAPHY AND DOES NOT INTERFERE WITH THE IDENTIFICATION AND QUANTITATION OF ETHANOL, IT DOES CO-ELUTE WITH METHANOL ON ONE OF OUR COLUMNS. WE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10603172 ↗
• MalfunctionMar 23, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE TUBES ARE CLOTTING DURING USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE CLOTTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865381 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE TUBES BROKE AFTER USE. THE SPECIMENS WERE PLACED IN THE FREEZER, VARYING "FROM SEVERAL DAYS TO WEEKS", AND THE GLASS BROKE DURING THE THAWING PROCESS. 1 TUBE BROKE ON 02/20/2020, WITH 4 OTHER TUBES BREAKING ON AN UNKNOWN DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED CALL FROM CUSTOMER WHOM STATED THEY ARE EXPERIENCING GLASS BREAKAGE. THIS IS OCCURRING AFTER SPECIMEN COLLECTION. CUSTOMER IS PLACING SPECIMEN IN FREEZER WHICH VARIES FROM SEVERAL DAYS TO WEEKS. GLASS IS BREAKING DURING THAWING PROCESS. NO EXPOSURE TO BLOOD, NO SERIOUS INJURY, NO ERRONEOUS RESULTS, NO COURSE OF TREATMENT CHANGE AND NO NEEDLE STICK. POSSIBLE SAFETY ISSUE AS GLASS SHARDS WERE EXPOSED BUT CONFIRMED NO INJURIES. DATE OF OCCURRENCE IS TODAY 02/20/2020 WITH ONE OCCURRENCE AND AN UNKNOWN DATE FOR 4 OCCURRENCES." "SPOKE WITH THE CUSTOMER, AND REFERRED HER TO THE STATEMENT IN THE IFU UNDER PRECAUTIONS THAT GLASS TUBE MAY BREAK AT OR BELOW 0C. SHE HAD THE IFU AND KNEW EXACTLY WHERE THE STATEMENT WAS, BUT HER GROUP THOUGHT THE BREAKAGE WAS UNIQUE TO THIS LOT#. I EXPLAINED THAT A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819042 ↗
• MalfunctionSep 19, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE HAS BEEN FOUND EXPERIENCING LOW DRAW DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367001 BATCH NO. UNKNOWN. IT WAS REPORTED THAT THERE ARE LOW BLOOD DRAWS. WE USE THE GREY STOPPER, 10ML, VACUTAINER VIALS AND HAVE HAD TO DEFEND OUR RESULTS IN COURT, WITH WHAT THE DEFENSE HAVE CALLED "LOW" BLOOD DRAWS. THE DEFENSE CLAIMS THAT THE VACUUM IN THE TUBES ARE FAULTY AND THAT IS THE REASON WHY AN AMOUNT LESS THAN THE 9.3-10.7 ML WAS COLLECTED. (OUR AVERAGE COLLECTION VOLUME IS 7ML FOR OUR COUNTY). FROM OUR EXPERIENCE THE CAUSE FOR A LOWER BLOOD VOLUME IS THAT THE PHLEBOTOMIST WASN'T PATIENT ENOUGH AND REMOVED THE VIAL BEFORE THE VACUUM WAS COMPLETELY USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9087421 ↗
• MalfunctionAug 23, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE FOAM TRAY HAD "RETENTION" WRITTEN ON IT WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG. THIS OCCURRED WITH 100 TUBES IN 1 SHELF PACK AND WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOAM TRAY HAS "RETENTION" WRITTEN ON IT UNDER THE PLASTIC WRAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928272 ↗
• MalfunctionAug 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE ADDITIVE WAS ABNORMAL. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367001, BATCH NO. 9036731. IT WAS REPORTED THAT THE ADDITIVE APPEARED TO BE DRIED AND STUCK TO THE SIDE OF THE TUBE. HE STATES THAT IN SOME OF THE TUBES (3 OUT OF THE 5 THAT HE RECENTLY CHECKED), THE ADDITIVE APPEARS TO BE DRIED AND STUCK TO THE SIDE OF THE TUBE, AND HE IS NOT SURE IF HE SHOULD USE IT. IT IS IN A KIT ASSEMBLED BY ADWIN KIT PACKERS. I EXPLAINED THAT IF THE TUBES DO NOT APPEAR NORMAL, HE SHOULD NOT USE THEM. HE MIGHT WANT TO CONTACT ADWIN TO GET REPLACEMENT TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8870635 ↗
• MalfunctionJul 31, 2019Leak/Splash; Leak/Splash

  MATERIAL NO: 367001, BATCH NO: 8187663. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES THE TUBE HAD A BROKEN LIP AS WELL AS STOPPER WAS NOT FITTING CORRECTLY IN TUBE (TOO SMALL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 TUBE WAS FROM CAT. NUMBER 367001, LOT NUMBER 8303636 AND HAD A BROKEN LIP (TOP OF GLASS TUBE). 5 TUBES WERE FROM CAT. NUMBER 367001, LOT NUMBER 8276658 AND HAD STOPPER ISSUES WHERE THE STOPPER WAS TOO SMALL TO FIT PROPERLY AND SEAL THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847333 ↗
• MalfunctionJul 17, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES WERE FOUND WITHOUT ADDITIVE. THIS OCCURRED ON 73 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367001 BATCH NO: 8187663. IT WAS REPORTED 73 TUBES WERE FOUND WITHOUT ADDITIVE. WE FOUND 73 TUBES WITHOUT ADDITIVE. THAT MEANS 273/300 HAVE NOW BEEN IDENTIFIED FROM THE (B)(4) LOT. DATE DISCOVERED WAS NOT INITIALLY PROVIDED BY CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799745 ↗
• MalfunctionJun 25, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  MATERIAL NO: 367001; BATCH NO:8187663. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG TUBES ARRIVED AT THE LABORATORY CLOTTED, AND WHOLE BLOOD TEST RESULTS HAD TO BE REPORTED QUALITATIVELY RATHER THAN QUANTITATIVELY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4 OF 9 PATIENTS AFFECTED BY THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER. BECAUSE OF THE CLOTTING, RESULTS HAD TO BE REPORTED QUALITATIVELY (I.E. PRESENT) RATHER THAN QUANTITATIVELY, AS WE ARE LEGALLY REQUIRED TO REPORT RESULTS OF WHOLE BLOOD. IT IS NOT CLEAR HOW THE CLOTTED SAMPLES WILL IMPACT THE IMPENDING CRIMINAL TRIALS.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730971 ↗
• MalfunctionJun 25, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  MATERIAL NO: 367001, BATCH NO:8187663. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG TUBES ARRIVED AT THE LABORATORY CLOTTED, AND WHOLE BLOOD TEST RESULTS HAD TO BE REPORTED QUALITATIVELY RATHER THAN QUANTITATIVELY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 9TH OF 9 PATIENTS AFFECTED BY THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER. BECAUSE OF THE CLOTTING, RESULTS HAD TO BE REPORTED QUALITATIVELY (I.E. PRESENT) RATHER THAN QUANTITATIVELY, AS WE ARE LEGALLY REQUIRED TO REPORT RESULTS OF WHOLE BLOOD. IT IS NOT CLEAR HOW THE CLOTTED SAMPLES WILL IMPACT THE IMPENDING CRIMINAL TRIALS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730844 ↗
• MalfunctionJun 25, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  MATERIAL NO: 367001 BATCH NO:8187663 IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG TUBES ARRIVED AT THE LABORATORY CLOTTED, AND WHOLE BLOOD TEST RESULTS HAD TO BE REPORTED QUALITATIVELY RATHER THAN QUANTITATIVELY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 8TH OF 9 PATIENTS AFFECTED BY THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER. BECAUSE OF THE CLOTTING, RESULTS HAD TO BE REPORTED QUALITATIVELY (I.E. PRESENT) RATHER THAN QUANTITATIVELY, AS WE ARE LEGALLY REQUIRED TO REPORT RESULTS OF WHOLE BLOOD. IT IS NOT CLEAR HOW THE CLOTTED SAMPLES WILL IMPACT THE IMPENDING CRIMINAL TRIALS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730842 ↗
• MalfunctionJun 21, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE TUBES WERE ARRIVE CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. (PATIENT 7/9). I AM CONTACTING YOU IN REGARDS TO THE ATTACHED BATCH OF GRAY TOP TUBE KITS WE HAVE RECEIVED INTO OUR LABORATORY AS CASE SPECIMENS. WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER." 7 OCCURRENCES WERE REPORTED AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724749 ↗