BD Vacutainer® Trace Element Serum Blood Collection Tubes 368380Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 30382903683803), received between Nov 27, 2017 and Apr 20, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES, THE MANGANESE LEVELS OF FIVE TUBES WERE ERRONEOUS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932757 ↗
• MalfunctionSep 9, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES, IMPROPER SEPARATION WAS SEEN IN ONE TUBE RESULTING IN SAMPLE RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009192 ↗
• MalfunctionSep 2, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WITHOUT SAMPLE EXPERIENCED A TEMPERATURE EXCURSION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946370 ↗
• MalfunctionAug 18, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834985 ↗
• MalfunctionAug 18, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834979 ↗
• MalfunctionAug 1, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES THE NEGATIVE PRESSURE IN THE TUBES IS LOW TO NONE AND AMOUNT OF BLOOD DRAWN DOES NOT MEET DETECTION REQUIREMENTS. NO PATIENT IMPACTED WAS REPORTED AND THERE IS 600 AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING BLOOD, THE NEGATIVE PRESSURE IN THE TUBE IS LOW/NONE, AND THE AMOUNT OF BLOOD DRAWN CANNOT MEET THE DETECTION REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17433331 ↗
• MalfunctionSep 16, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED MISSING LABEL INFORMATION AFTER BEING TORN. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TUBE LABEL WAS FOUND TO BE TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435375 ↗
• MalfunctionJul 12, 2022Material Discolored; Material Discolored

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBE THE COLOR OF THE LABEL WAS SIMILAR TO ANOTHER PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER IS REPORTING CONCERN "A MIX-UP IS NOT ONLY POSSIBLE BUT PROBABLE SINCE PRODUCTS 368380 AND 368381 LOOK SO SIMILAR AND PATIENT HARM IS A POSSIBILITY." PRODUCT 368380 IS LABELED SERUM WITH A RED STRIPE AND PRODUCT 368381 IS LABELED K2 EDTA AND WITH A LAVENDER STRIPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991976 ↗
• MalfunctionJul 28, 2021Illegible Information; Illegible Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® NH (SODIUM HEPARIN) 170 I.U. BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION (ALL PACKAGING LEVELS). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER OPENED A NEW TRAY AND FOUND ONE TUBE THAT HAS 2 STICKERS ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242805 ↗
• MalfunctionMay 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "UNEXPECTED HIGHER THAN USUAL ZINC VALUES IN VETERINARY SAMPLES. FOR 8 WEEKS, THEY SEE ELEVATES ZINC VALUES. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891161 ↗
• MalfunctionDec 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES THE GEL SMEARING OCCURRED. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRACE ELEMENT TUBE GELLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11028942 ↗
• MalfunctionOct 5, 2020Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE WITH A BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES THE TUBES WERE DISCOVERED TO BE DAMAGED DUE TO HEAT DURING TRANSIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED BUT THE SAMPLE COLLECTION TUBES PACKAGED IN THE PPD KIT BOX ARE ALL BROKEN. THERE ARE NO SCRATCH ON THE SURFACE OF THE TUBES BUT THEY ARE DEFORMED. LOOKING AT THE PICTURE, THE TEAM BELIEVES THAT THE TUBES ARE SOFTENED BY HEAT AND DEFORMED BY NEGATIVE PRESSURE. ACTUALLY, IN JAPAN, ESPECIALLY IN THE AREA OF THE SITE, THE MAXIMUM TEMPERATURE REACHES OVER 40 IN SUMMER AND IT MAY BE 50 ON SOME SPOTS IN DIRECT SUNSHINE. WHAT IS THE TEMPERATURE TOLERANCE OF THE TUBES ? HOW CAN WE PREVENT THE DEFORMATION IF THE TEMPERATURE WOULD BE WITHIN THE TOLERANCE ? THE AFFECTED TUBES WERE THE FOLLOWING BD TUBES . SERUM TUBE-6ML SILICONE COATED/CLOT ACTIVATOR (PLASTIC) - BD368380 . EDTA-2ML K2 3.6MG (PLASTIC)- BD-367841. EDTA-6ML K2 10.8MG (PLASTIC) - BD-367864 . IT IS ENTIRELY POSSIBLE THAT THE SHIPMENT WAS EXTREMELY MIS-HANDLED BY THE COURIER, BUT WE NEED TO HAVE AS MUCH INFORMATION AS POSSIBLE SO THAT WE CAN UNDERSTAND THE SITUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10627928 ↗
• MalfunctionJun 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE, FOREIGN MATTER WAS DISCOVERED IN TUBE WITH A BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FM WAS FOUND IN A TUBE BEFORE USE AND THE CONCERNED TUBE WAS THUS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 10164998 ↗
• MalfunctionJun 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BEFORE USE THE CUSTOMER HAD DIFFICULTY WITH THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES IN DISTINGUISHING BETWEEN THE K2EDTA AND SERUM CLOT ACTIVATOR (SILICONE COATED) TUBES WHICH RESULTS IN PUTTING THE SPECIMEN IN THE WRONG TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "WHEN COMPLETING TRACE METAL TESTING THEY HAVE A DIFFICULT TIME WITH THE COLLECTING SAMPLE AND USING THE CORRECT ROYAL BLUE TUBE." CUSTOMER STATES "ITS DIFFICULT TO DIFFERENTIATE BETWEEN EDTA AND TUBES WITH NO ADDITIVE. CLINICIANS LOOK AT THE CAP AND DO NOT PAY ATTENTION TO THE LABEL ON THE SIDE OF THE TUBE." THE LAB HAS TO CANCEL TESTS AND REQUEST REDRAWS BECAUSE THE WHOLE BLOOD SAMPLE WAS DRAWN IN THE SILICONE COATED TUBE AND CLOTTED PRIOR TO REACHING THE LAB FOR TRACE METAL ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128736 ↗
• MalfunctionNov 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS ERRONEOUS RESULTS WITH A BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES. TRACES OF COBALT, CHROMIUM, MOLYBDENUM, TIN AND VANADIUM WERE FOUND. THIS OCCURRED ON 10 SEPARATE OCCASIONS AFTER USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) THERE ARE TRACE AMOUNTS OF THE FOLLOWING IN THIS LOT NUMBER: COBALT, CHROMIUM, MOLYBDENUM, TIN AND VANADIUM (CONCENTRATION PRESENT IS CLOSE TO THE REFERENCE INTERVAL UPPER LIMIT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9304726 ↗
• MalfunctionNov 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368380 BATCH NO. 8215763. (2 OF 2) IT WAS REPORTED THAT THE AMOUNT OF ALUMINUM CONTAMINATION IS TWICE THE NORMAL RANGE FOR PATIENT SERUM RESULTS. THE NAVY TRACE METALS SERUM TUBES ARE CONTAMINATED WITH ALUMINUM. THE AMOUNT OF CONTAMINATION IS TWICE THE NORMAL RANGE FOR PATIENT SERUM RESULTS. THERE ARE PATIENTS THAT HAVE THEIR ALUMINUM LEVELS TESTED YEARLY AND THEIR RESULTS HAVE GONE FROM BEING WITHIN THE NORMAL RANGE TO MORE THAN TWICE THE NORMAL RANGE. THE PATIENT SAMPLES ARE REFERRED TO US FROM ALL OVER ONTARIO AND I DO NOT HAVE THE LOT NUMBERS FOR THE TUBES THAT WERE USED. I DO NOT KNOW HOW THE COURSE OF TREATMENT WAS CHANGED BASED ON THE ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9273856 ↗
• MalfunctionNov 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING ERRONEOUS RESULTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PATIENTS RESULTS TESTED WERE CONTAMINATED WITH ALUMINUM. CUSTOMER REPORTS THAT THIS ISSUE OCCURRED TODAY BUT HAS NOTICED OVER THE YEAR THAT HER PATIENTS RESULTS HAVE SHIFTED UP, PATIENTS RESULTS HAVE BEEN AFFECTED. SHE DOES NOT KNOW THE LOT NUMBER SINCE THEY ARE JUST SENT TO HER FOR TESTING. THERE ARE NO UNUSED SAMPLES TO BE SENT IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9266755 ↗
• MalfunctionMar 4, 2019Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation

  IT WAS REPORTED THAT BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES WERE STORED AT THE WRONG TEMPERATURE AND THEY MELTED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "CUSTOMER DISTRIBUTE TUBES FOR UNITS OF EXTERNAL COLLECT. THE PATH WITH CAR TAKES AT MAXIMUM 60 MINUTES. FOR HIS SURPRISE, WHEN HE CAME TO THE FINAL DESTINATION, THE TUBES WERE "MELT." IT WAS TRANSPORTED IN CARDBOARD BOX. OTHERS, HAD MAKE THE TEST WITH TRANSPARENT PLASTIC BAG AND THE PROBLEM REPEATED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387742 ↗
• MalfunctionJan 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® TRACE ELEMENT SERUM HAD FOREIGN MATTER INSIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8216480 ↗
• MalfunctionOct 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "BROKEN PIECE OF PLASTIC" WAS FOUND IN THE BD VACUTAINER TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947755 ↗
• MalfunctionJun 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES HAD ABNORMAL ADDITIVE FORM ISSUE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593031 ↗
• MalfunctionMay 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES HAD "FM UNKNOWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548998 ↗
• MalfunctionMay 8, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES HAD CLOTTING. NO SERIOUS INJURY MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494380 ↗
• MalfunctionApr 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES HAD ERRONEOUS RESULTS DUE TO LABELING PLACEMENT.

  Patient problems: No Information

  MAUDE report 7466976 ↗
• MalfunctionApr 20, 2018No Device Output; No Device Output

  IT WAS REPORTED THAT THE INSTRUMENTATION WAS BLOCKED OR CLOGGED WHILE USING THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7449080 ↗