BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube 364958Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 50382903649582), received between Dec 5, 2017 and Sep 9, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 reports).

3 other recalls cover devices cleared under the same FDA submission (K024240); they may or may not involve this specific model.

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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT INCREASED HEMATURIA COMPARED TO OTHER LABORATORIES IN THE REGION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006369 ↗
• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT INCREASED HEMATURIA COMPARED TO OTHER LABORATORIES IN THE REGION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000124 ↗
• MalfunctionMay 28, 2025Leak/Splash; Leak/Splash

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF CAPS WERE LOOSE WHILE ON THEIR AUTOMATED INSTRUMENT RESULTING IN SPILLED SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100521 ↗
• MalfunctionMay 28, 2025Leak/Splash; Leak/Splash

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, 9 CAPS WERE LOOSE WHILE ON THEIR AUTOMATED INSTRUMENT RESULTING IN SPILLED SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100492 ↗
• MalfunctionMay 5, 2025Leak/Splash; Leak/Splash

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT STOPPER CREEPOUT AFTER REPLACING CAP RESULTING IN SPILLS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964590 ↗
• MalfunctionMay 5, 2025Leak/Splash; Leak/Splash

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT STOPPER CREEP OUT AFTER REPLACING CAP RESULTING IN SPILLS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964585 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE , AN UNSPECIFIED NUMBER OF STOPPERS DID NOT STAY CLOSED AFTER RECAPPING ON THEIR AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667604 ↗
• MalfunctionMar 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RECAPPING PROPERLY ON THEIR AUTOMATED INSTRUMENT; SOME TUBES EXHIBIT LOOSE CAPS PRIOR TO USE. TUBES WITH LOOSE CAPS ARE OVERFILLING WHEN USING THE STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593679 ↗
• MalfunctionMar 12, 2025Leak/Splash; Overfill; Leak/Splash; Overfill

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RECAPPING PROPERLY ON THEIR AUTOMATED INSTRUMENT; SOME TUBES EXHIBIT LOOSE CAPS PRIOR TO USE. THOSE TUBES WITH LOOSE CAPS ARE OVERFILLING WHEN USING THE STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588028 ↗
• MalfunctionMar 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, 30 SAMPLES LEAKED DURING TRANSPORT OR ON AUTOMATION LINE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546448 ↗
• MalfunctionMar 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE PERFORMING A VALIDATION RUN ON THE WASP INSTRUMENT THAT BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBES HAD A MISALIGNMENT OF THE CLOSURE MAKING IT DIFFICULT FOR THE INSTRUMENT TO DECAP AND CAP. A CAP POPPED OFF CAUSING SPECIMEN TO SPILL IN THE ANALYZER. THE CUSTOMER ALSO NOTICED SOME LOOSE CLOSURES BEFORE SAMPLE ANALYSIS ON THE INSTRUMENT. THESE REPORTED DEFECTS OCCURRED AN UNSPECIFIED NUMBER OF TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537133 ↗
• MalfunctionFeb 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES HAD LOOSE CAPS LEADING TO SPILLS OF THE SAMPLE IN THEIR AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459265 ↗
• MalfunctionFeb 19, 2025Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING SPILLS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417636 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING SPILLS AND SPLASHES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406075 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING URINE TO SPILL ON LAB BENCH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403337 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING SPILLS AND SPLASHING LABORATORY WORKER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401838 ↗
• MalfunctionJan 29, 2025Leak/Splash; Leak/Splash

  REPORT 1 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP) ; CAPS ARE LOOSE AND CAUSING SPILLS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265527 ↗
• MalfunctionJan 29, 2025Leak/Splash; Leak/Splash

  REPORT 2 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, 1 TUBE WAS NOT RESEATED ON THEIR AUTOMATED INSTRUMENT (COPAN WASP) AND THE CAP WAS LOOSE. A LAB ASSISTANT PICKED UP THE TUBE BY THE CAP AND THE TUBE FELL ON THE FLOOR AND URINE SPLASHED ON THEIR EAR. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265351 ↗
• MalfunctionAug 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, FOREIGN MATTER (CORING) WAS FOUND IN TWENTY-FOUR (24) PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954937 ↗
• MalfunctionJul 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING USE OF BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE AN UNSPECIFIED NUMBER OF CAPS/SHIELDS WERE DEFECTIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732148 ↗
• MalfunctionJun 12, 2024Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE THE ADDITIVE WAS MISSING IN AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524944 ↗
• MalfunctionOct 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE CONTAMINATION OF THE TUBE WAS SUSPECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OVER THE PAST FEW DAYS, THE LABORATORY HAS BEEN ISOLATING BURKHOLDERIA FROM URINE SAMPLES, WHICH WERE CONFIRMED TO BE STERILE AFTER RE-CHECKING. THEY ARE CURRENTLY INVESTIGATING, AND ONE OF THEIR LEADS MAY BE A CONTAMINATION OF BATCH 3073801 OF BORATE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981596 ↗
• MalfunctionJul 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, THE DEVICE EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I HAVE THE SAFETY DATA SHEET FOR THE BD VACUTAINER® BORIC ACID TUBE SODIUM BORATE / FORMATE C&S URINE TUBE WHICH INDICATES THE FOLLOWING PICTOGRAM, BUT ON THE PRODUCT I STILL HAVE THE PICTOGRAMS OF THE OLD REGULATIONS WHICH ARE NO LONGER APPLICABLE SINCE 2015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124420 ↗
• MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE DEVICE EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PROBLEMS WITH AUTOMATED DECAPPING OF TUBES. TO SOLVE THIS, THE CAPS ARE VERY LIGHTLY TAPPED BY HAND, THUS VENTILATING THE TUBE. AFTER THIS MANIPULATION, THE AUTOMATIC PROCESSING OF THE TUBES ON THE INOQULA WORKS WITHOUT FURTHER PROBLEMS. THE DIFFICULTIES WITH THE AUTOMATIC DECAPPING OF THE 4 ML BD VACUTAINER URINE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935968 ↗
• MalfunctionApr 29, 2021Missing Information; Missing Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE THERE WAS NO LABEL OR MISSING LABEL INFORMATION THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE ARRIVED WITHOUT A LABEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024240. One submission often covers many models, so check the product and lot details in each record.

• Z-1024-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contai
• Z-1023-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collectio
• Z-1025-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C.