BD Vacutainer® No Additive (Z) Tubes 366703Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 30382903667032), received between Oct 17, 2017 and Sep 11, 2026 — classified as 1 injury, 142 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (66 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 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Short Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736891 ↗
• MalfunctionJul 7, 2025Separation Problem; Separation Problem

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) TUBES, STOPPER POP OFF OCCURRED 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 22413590 ↗
• MalfunctionJul 7, 2025Separation Problem; Separation Problem

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) TUBES, STOPPER POP OFF OCCURRED 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 22413566 ↗
• MalfunctionJul 17, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THERE ARE RUBBER FLAKES BREAKING OFF FROM ORANGE STOPPER AND CONTAMINATING THE SAMPLES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767930 ↗
• MalfunctionJul 16, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THE RUBBER FLAKES ARE BREAKING OFF FROM THE ORANGE STOPPER AND CONTAMINATING THE SAMPLES. MORE THAN 692SAMPLES AFFECTED. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752850 ↗
• MalfunctionJul 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE TRANSFERRING A SAMPLE INTO THE BD VACUTAINER® NO ADDITIVE (Z) TUBES WITH A HEMA SOURCE SYRINGE, THE STOPPER IS FLAKING OFF AND CONTAMINATING THE SAMPLE RENDERING IT UNUSABLE. THIS RESULTED IN ADDITIONAL SAMPLES NEEDING TO BE PULLED, BUT NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752849 ↗
• MalfunctionApr 17, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH ONE PACK OF BD VACUTAINER® NO ADDITIVE (Z) TUBES, THE TUBE CAPS WERE DISCOLORED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128015 ↗
• MalfunctionNov 9, 2023Material Discolored; Material Discolored

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES HAVE A DIFFERENT COLOR CAP ON IT. NO IMPACT ON PATIENTS OR USERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER PROBLEM: CUSTOMER STATES GOLD TOP CLOSURE WAS ON A NONADDITIVE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107538 ↗
• MalfunctionSep 21, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® NO ADDITIVE (Z) TUBES THE TUBE UNDERFILLED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING UNDERFILL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796002 ↗
• MalfunctionAug 30, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® NO ADDITIVE (Z) TUBES FOREIGN MATTER WAS DISCOVERED IN TUBE. THIS OCCURRED WITH 6-8 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING FOREIGN MATTER IN TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651699 ↗
• MalfunctionAug 30, 2023Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® NO ADDITIVE (Z) TUBES FOREIGN MATTER WAS DISCOVERED IN ABOUT 20 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING FOREIGN MATTER IN TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651427 ↗
• MalfunctionAug 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES CUSTOMER FOUND FOREIGN MATTER IN THE TUBE. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED ¿ STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THIS IS THE 3RD FACILTIY WHICH SHE CONFIRMED ON 8/9/23 VIA EMAIL. CLIENTS RECEIVED TUBES THAT HAD FOREIGN MATTER IN THE TUBES. THERE WAS NO PATIENT HARM. WHEN THEY SAW THAT THE TUBES HAD FOREIGN MATTER THEY USED DIFFERENT TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514911 ↗
• MalfunctionAug 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES CUSTOMER FOUND FOREIGN MATTER INSIDE THE TUBE. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER PROBLEM: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBER 3111788. RELATED TO CASE (B)(4) . STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THIS IS THE SECOND FACILITY CONFIRMED ON 8/9/2023. CLIENTS RECEIVED TUBES THAT HAD FOREIGN MATTER IN THE TUBES. THERE WAS NO PATIENT HARM. WHEN THEY SAW THAT THE TUBES HAD FOREIGN MATTER THEY USED DIFFERENT TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514909 ↗
• MalfunctionAug 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL IN THREE DIFFERENT TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBERS 3048751, 2227106, AND 3111788.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500105 ↗
• MalfunctionMay 31, 2023Component Missing; Activation, Positioning or Separation Problem; Component Missing; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THE NO ADDITIVE TUBE IS CLOTTING WITHIN 30 MIN AFTER BLOOD COLLECTION. NOT ALLOWING PIPETTING.

  Patient problems: Insufficient Information

  MAUDE report 17035456 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THE TUBE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SAMPLE TUBES CRACKED ONCE FROZEN. TUBES FROZEN BETWEEN THE TEMPERATURES OF -35C TO -40C."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368354 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THE TUBE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SAMPLE TUBES CRACKED ONCE FROZEN. TUBES FROZEN BETWEEN THE TEMPERATURES OF -35C TO -40C."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368287 ↗
• MalfunctionJan 9, 2023Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem; Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE, THE DEVICE EXPERIENCED MISSING ADDITIVE AND THERE WAS POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AFTER MULTIPLE ATTEMPTS OF CONTACT NO FURTHER INFORMATION WAS PROVIDED, SETTING THIS CASE TO PC. 366703 TUBE PLN PLH 13X75 3.0 SMALL AMOUNT OF SERUM OBTAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127353 ↗
• MalfunctionAug 1, 2022Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "NON-BD CAPS ARE POPPING OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141382 ↗
• MalfunctionJun 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A FOREIGN MATTER WAS FOUND ON THE NEEDLE CONNECTION SITE OF THE CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789656 ↗
• MalfunctionJun 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 46 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE ARE "BLACK SPOTS (EMBEDDED FOREIGN MATTER) ON TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789527 ↗
• MalfunctionJun 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES THERE WAS A PRESENCE OF MOLD. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS IS A REPORT ABOUT BLACK SPOTS (EMBEDDED FM) ON TUBES. THIS CUSTOMER HAS PREVIOUSLY REPORTED THE SAME ISSUE, WITH NO IMPROVEMENT IN THE PRODUCT, THE CUSTOMER IS STRONGLY COMPLAINING THE RECURRENCE OF THIS ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789486 ↗
• MalfunctionApr 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBE HAD A PLASTIC PIECE IN THEM. "PLASTIC PIECE FOUND IN TUBE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13999479 ↗
• MalfunctionMar 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT AFFECTED 29 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLACK SPOTS WERE FOUND ON SEVERAL TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905739 ↗
• MalfunctionFeb 8, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) 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: "NO BLOOD WAS DRAWN DURING BLOOD COLLECTION USING THE WINGSET SLBCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481216 ↗