BD Vacutainer® Urinalysis Urine Tube 364979Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 30382903649793), received between Oct 30, 2017 and Apr 20, 2026 — classified as 29 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS URINE TUBE, FOREIGN MATTER WAS SEEN INSIDE OF 100 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930494 ↗
• MalfunctionFeb 10, 2026Short Fill

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS URINE TUBE, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305937 ↗
• MalfunctionFeb 10, 2026Short Fill

  REPORT 1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS URINE TUBE, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305928 ↗
• MalfunctionJan 15, 2026Short Fill

  IT WAS REPORTED BY CUSTOMER THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079438 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING VALIDATION OF BD VACUTAINER® URINALYSIS URINE TUBE, CAPS ARE CREEPING OFF IN AN UNSPECIFIED NUMBER OF TUBES AFTER TUBES ARE OPENED AND RECAPPED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612466 ↗
• MalfunctionDec 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO COLLECTION OF BD VACUTAINER® URINALYSIS URINE TUBE IN AN INTERNAL STUDY, 1 TUBE DID NOT HAVE A LABEL. THE TUBE WAS REPLACED AND COLLECTION CONTINUED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853075 ↗
• MalfunctionAug 11, 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® URINALYSIS URINE TUBE FOREIGN MATTER WAS DISCOVERED IN MULTIPLE AREAS OF THE TUBES AND CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT UPON THEIR QUALITY INSPECTION THEY DETECTED THE TUBES FROM LOT#: 3111770 SHOWED DEBRIS OR FOREIGN MATTER ON THE CAP OF THE TUBES. THE FOREIGN OBJECT IS PRESENT ON MULTIPLE PARTS AND IN MULTIPLE AREAS. THE LOT WAS REJECTED. AND PULL FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514715 ↗
• MalfunctionMar 24, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® URINALYSIS URINE TUBE THE SAMPLE APPEARED DISCOLORED "GREEN". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THEY DETECTED A COLOR VARIATION ON THE URINE SAMPLE COLLECTED ON THE NO ADDITIVE TUBES 364979. CUSTOMER REPORTED THE SAMPLE FROM THE SAME PATIENT WAS COLLECTED ON THE 364951 TUBE AND IN THE 364979 TUBE. THE SAMPLE FROM TUBE 364951 SHOWS A REGULAR YELLOW COLORATION, MEANWHILE THE SAMPLE COLLECTED ON 364979 TUBE SHOWED A GREEN COLORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613587 ↗
• MalfunctionNov 9, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS URINE 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: PRESSURE WAS LOST DURING THE FIRST STICK. IN A BD SPONSORED TRIAL STUDY, THE PRODUCT 364979, LOT# 1074704 REPORTED TO HAVE VACUUM PRESSURE LOSS DURING THE FIRST ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760007 ↗
• MalfunctionAug 1, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS URINE 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: "WHEN THE URINE TUBE IS INSERTED THERE IS NO BLOOD FLOW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141347 ↗
• MalfunctionMar 8, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS URINE TUBE THERE WAS TUBE EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TOPS ARE SMALLER CAUSING THE ANALYZER TO DROP THE SAMPLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698972 ↗
• MalfunctionJan 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD TUBE URIN PLC 16X100 10.0 UA YEL, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE PRODUCT WAS DIRTY. THERE WAS 1CS OF PART # 364979 THAT WAS REJECTED FROM PO # (B)(4). THE CASE CAME IN OPEN AND PRODUCT INSIDE IS DIRTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309285 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS URINE TUBE THERE WAS CRACKED TUBE. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533166 ↗
• MalfunctionAug 11, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS URINE TUBE , THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I¿M REACHING OUT IN REGARDS TO THE 10ML BD UA NO ADDITIVE TUBE. WE HAVE IDENTIFIED THAT TUBES OF THIS LOT NUMBER IS NO LONGER DRAWING ALL 10ML OF LIQUID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309107 ↗
• MalfunctionOct 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® URINALYSIS URINE TUBE THERE WAS LOOSE CLOSURE AND BLOOD LEAKAGE OCCURRED, ALSO CRACKED TUBES. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBES LEAKED BECAUSE THE TOP HAS COME OFF OR PARTIALLY OFF AND IN SOME CASES THE TUBE HAS CRACKED.

  Patient problems: No Patient Involvement

  MAUDE report 10673089 ↗
• MalfunctionMar 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® URINALYSIS URINE TUBE THERE WAS BLACK FOREIGN MATTER FOUND INSIDE THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401256 ↗
• MalfunctionOct 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® URINALYSIS URINE TUBE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949509 ↗
• MalfunctionSep 25, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® URINALYSIS URINE TUBES ARE UNDERFILLING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906278 ↗
• MalfunctionAug 1, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN TRANSFERRING URINE FROM URINE CUPS WITH INTEGRATED TRANSFER DEVICE INTO AT BD VACUTAINER® URINALYSIS URINE TUBES, BUBBLES FORMED IN THE CONICAL OF THE TUBES WHICH CAUSED THE INSTRUMENT TO READ THEM ERRONEOUSLY AS FALSE POSITIVE RED BLOOD CELLS. THE DOCTOR RECALLED THE PATIENTS TO GET RETESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739623 ↗
• MalfunctionJul 11, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION TUBES HAD INCONSISTENT VACUUM PERFORMANCE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678726 ↗
• MalfunctionJun 20, 2018Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT BD VACUTAINER® URINALYSIS URINE TUBES WERE COLLAPSED. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620735 ↗
• MalfunctionJun 5, 2018Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT BD VACUTAINER® URINALYSIS URINE TUBES WERE CRUSHED. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569549 ↗
• MalfunctionMay 10, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE BD VACUTAINER® URINALYSIS URINE TUBE RUBBER STOPPERS WERE INTERFERING WITH THE TESTING.

  Patient problems: No Information

  MAUDE report 7503367 ↗
• MalfunctionApr 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® URINALYSIS URINE TUBE HAD FOREIGN MATTER.

  Patient problems: No Information

  MAUDE report 7466732 ↗
• MalfunctionApr 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® URINALYSIS URINE TUBE HAD FOREIGN MATTER ON THE STOPPER. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7431422 ↗