BD Vacutainer® Urine Complete Cup Kit 364956Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 50382903649568), received between Dec 1, 2017 and Sep 16, 2025 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (8 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT, THE SOAP TOWELETTES IN 20 KITS WERE DRY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067227 ↗
• MalfunctionAug 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, AN UNSPECIFIED NUMBER OF KITS CONTAIN TOWELETTES WHICH BREAK APART EASILY AND ARE DIFFICULT TO CLEANSE PROPERLY. CUSTOMER HAS REPORTED AN INCREASE IN CONTAMINATED URINE SAMPLES. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731383 ↗
• MalfunctionJul 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNKNOWN FOREIGN MATTER INSIDE ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512110 ↗
• MalfunctionJun 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS SAMPLE LEAKAGE ON 5 DEVICES EVEN WHEN THE LID WAS SECURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127002 ↗
• MalfunctionApr 22, 2025Off-Label Use; Short Fill; Inaccurate Information; Off-Label Use; Short Fill; Inaccurate Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS SHORT FILL IN AN UNSPECIFIED NUMBER OF DEVICES. IT WAS THEN DISCOVERED THAT THE EXPIRATION DATE ON THE SHELF LABEL WAS BEYOND THE EXPIRATION DATE OF THE TUBE. THE EXPIRATION DATE ON THE TUBE LABEL HAD ALREADY PASSED SO AN EXPIRED TUBE WAS USED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883472 ↗
• MalfunctionMar 31, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, TWO (2) TUBES UNDERFILLED AND LOST SUCTION AFTER 1ML. SAMPLE WAS REDRAWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734313 ↗
• MalfunctionFeb 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT, AN UNSPECIFIED NUMBER OF KITS HAD OPEN AND DRY TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378886 ↗
• MalfunctionJan 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT THAT ONE HUNDRED AND TWENTY-THREE KITS (123) HAD OPEN AND DRY TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129904 ↗
• MalfunctionJan 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT THAT EIGHTY-SIX (86) KITS HAD OPEN AND DRY SOAP TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064029 ↗
• InjuryMay 7, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED WHILE USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THAT THE NEEDLE REMAINED IN THE VACUTAINER TUBE WHEN THE SAMPLE WAS REMOVED FROM THE URINE COLLECTION CUP. A HEALTHCARE WORKER RECEIVED A MINOR ABRASION ON THEIR THUMB WHEN HANDLING THE VACUTAINER TUBE. POST EXPOSURE BLOOD WORK WAS OBTAINED AND TESTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN AN EMPLOYEE WENT TO REMOVE THE VACUTAINER TUBE FROM THE URINE COLLECTION CUP LID NEEDLE, THE NEEDLE CAME OUT OF THE LID. CUSTOMER WASN'T EXPECTING THE NEEDLE TO BE ON TOP OF A TUBE, AND WENT TO PUT THE TUBE DOWN WHICH RESULTED IN A MINOR ABRASION ON HER THUMB. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? YES, THE BLOODWORK IS UNDERWAY, AND THE PATIENT INFORMATION AND RESULTS ARE AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262394 ↗
• InjuryNov 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHEN USING AN BD VACUTAINER® URINE COMPLETE CUP KIT DURING THE PROCESS OF PREPARING OR COMPLETING TRANSFER TO THE COLLECTION TUBE NURSES ARE ACCIDENTLY INSERTING THEIR FINGER IN THE RECESSED SHARPS AREA, WHICH CAUSED A NEEDLESTICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: -CUSTOMER PROBLEM: CUSTOMER REPORTS NEEDLESTICK INJURIES WHILE USING BD URINE COLLECTION CUPS. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER PIR3068079, CUSTOMER STATES NURSING STAFF IS EXPERIENCING NEEDLESTICKS WITH THE URINE COLLECTION CUPS. PER CUSTOMER, IN THE PROCESS OF PREPARING OR COMPLETING TRANSFER TO THE COLLECTION TUBE NURSES ARE ACCIDENTLY INSERTING THEIR FINGER IN THE RECESSED SHARPS AREA. TWO DIFFERENT PRODUCT NUMBERS WERE PROVIDED, 364956 AND 364975.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18066342 ↗
• MalfunctionAug 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® URINE COMPLETE CUP KIT TUBES WERE MISSING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT ALL PACKS WERE MISSING THE 4 ML PRESERVATIVE TUBE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495459 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® URINE COMPLETE CUP KIT, SAMPLES LEAKED OUT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CUPS ARE LEAKING FREQUENTLY AND THEY HAD TO STOP USING THEM. THE STAFF WOULD COLLECT THE URINE AND ATTEMPT TO SCREW THE CAP BACK ON THE CUP AND HAD DIFFICULT WITH GETTING THE CAP TO COMPLETELY SCREW ON. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? ON OCCASION. DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259424 ↗
• MalfunctionApr 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INTERMITTENT LEAKING OF A SPECIMEN DESPITE LID TIGHTLY CLOSED. THERE WAS NO EXPOSURE OR MEDICAL INTERVENTIONS. THE LEAKAGE CAME FROM THE LID AND THE SPECIMEN WAS TRANSPORTED IN A PLASTIC SPECIMEN BAG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255880 ↗
• MalfunctionMar 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT, THE DEVICE EXPERIENCED STOPPER CREEP OUT / LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: URINE LEAKAGE; SPECIMEN LID DOES NOT SEAL WELL - EVEN WHEN USER TWISTS THE LID TIGHTLY. WHEN SPECIMENS GET SENT TO LAB VIA THE PNEUMATIC TUBE SYSTEM, URINE LEAKAGE ARE VERY OFTEN REPORTED BY LAB CAREGIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778900 ↗
• MalfunctionFeb 4, 2022Material Opacification; Material Opacification

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KITS, THE DEVICE EXPERIENCED DRY SOAP TOWELETTES. THIS EVENT OCCURRED 50 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THEIR ARE CUTS INSIDE THE KITS THAT ARE MAKING THE WIPES DRY, THEREFOR DEFECTIVE. " ONE OF THE NORTHSIDE DEPARTMENTS OPENED A KIT AND THE WIPE INSIDE THE KIT HAS A CUT PACKAGE. SHE SAID APPEARS THAT ALL OF THE KITS IN HER CASE ARE DEFECTIVE. THIS HAS RESULTED IN THE WIPES BEING DRY. THE OUTSIDE OF THE PRODUCT HAS NOT BEEN COMPROMISED, SO IT APPEARS TO HAVE HAPPENED AT THE MANUFACTURING LEVEL. " COMPLAINT RATIONALE ¿ BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿REFER TO COMPLAINT DETERMINATION DECISION TREE (NASSC-RCC-007).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13458798 ↗
• MalfunctionJan 13, 2021Leak/Splash; Short Fill; Volume Accuracy Problem; Leak/Splash; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER¿ URINE COMPLETE CUP KIT UNDERFILLED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 364956, BATCH NO: 0281691. IT WAS REPORTED THAT THE TUBE IS LEAKING AND IS NOT FILLING PROPERLY. DATE: (B)(6) 2020. TIME: 10 AM. HARM: NONE. ID: (B)(6). DEPARTMENT: ED. DESCRIPTION: URINE WOULD NOT FLOW INTO TUBE. TRY TO MANUALLY FILL WITH BLANK TIP (I THINK BLUNT TIP WAS MEANT) AND NOTED LEAKING AROUND RUBBER STOP IN TUBE AND SMALL LEAK IN TUBE ITSELF. PRODUCT SAVED: YES. MANF #: 364956 LOT # UNKNOWN AT THIS TIME. AFFECT PRODUCT: 1 KIT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11166774 ↗
• MalfunctionDec 15, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® URINE COMPLETE CUP KIT EXPERIENCED UNDER-FILL OR LOW DRAW. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE URINE C&S VACUTAINER INCLUDED IN KIT WOULD NOT FILL UP. NO HARM TO PATIENT. POTENTIAL HARM TO STAFF, WITH BIO-HAZARD EXPOSURE. THE SPEC TUBE IN THE URINE KIT WERE NOT FILLING UP, USED 2 KITS TO TRY AND BOTH KITS THE SPEC TUBES WERE NOT FILLING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11015060 ↗
• MalfunctionNov 18, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® URINE COMPLETE CUP KIT EXPERIENCED UNDER-FILL OR LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THERE WAS A "FILLING ISSUE WHEN USING URINE TUBE THAT IS INCLUDED IN URINE KIT. THE CUSTOMER "COULD NOT GET URINE TO SUCTION INTO TUBES. UNSURE IF IT WAS FAULTY TUBES OR LID ON CUP. OPENED ANOTHER KIT AND POURED URINE INTO A NEW CUP AND WAS ABLE TO TRANSFER URINE TO NEW TUBES.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10865231 ↗
• MalfunctionNov 18, 2020Leak/Splash; Short Fill; Volume Accuracy Problem; Leak/Splash; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND SAMPLE LEAKAGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THERE WAS LEAKAGE WHEN USING URINE CUP AS WELL AS UNDERFILLING OF C&S TUBE INCLUDED IN KIT. REPORTER TRIED TWO DIFFERENT CUPS AND WHEN TRYING TO INSERT URINE INTO SPECIMEN TUBES THERE WAS A MALFUNCTION AND URINE WAS NOT DISPENSED INTO TUBES FROM CUP. MINIMAL URINE IN YELLOW TUBE, NO URINE IN GRAY TUBE THIS HAPPENED TWO TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10865194 ↗
• MalfunctionNov 18, 2020Leak/Splash; Short Fill; Volume Accuracy Problem; Leak/Splash; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THERE WAS LEAKAGE WHEN USING URINE CUP AS WELL AS UNDERFILLING OF C&S TUBE INCLUDED IN KIT. THE CUPS LEAK CAUSING URINE TO SPILL ALL OVER THE PLACE. BD TEAM: REPORTING PRODUCT CONCERN. PRODUCT WAS NOT SAVED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10865187 ↗
• MalfunctionOct 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 7 BD VACUTAINER® URINE COMPLETE CUP KIT EXPERIENCED SAMPLE LEAKAGE DURING USE/SAMPLE COLLECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364956, BATCH NO. 9121872. SEVEN INCIDENT REPORTS REGARDING THIS ITEM LAST NIGHT ABOUT THEM LEAKING. I GOT ONE AND FILLED IT WITH WATER TO TRY MYSELF AND IT DID LEAK, FROM END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9239824 ↗
• MalfunctionAug 15, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® URINE COMPLETE CUP KIT HAS BEEN FOUND EXPERIENCING ERRONEOUS RESULTS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364956, BATCH NO. UNKNOWN. IT WAS REPORTED THAT CLEANSING WIPES DO NOT HELP TO REDUCE FALSE POSITIVE UA OR URINE CULTURE RESULTS. CUSTOMER IS OF THE OPINION, BASED ON RESEARCH AND SUBJECT MATTER EXPERTISE, THAT CLEANSING WIPES (AND FOR THAT MATTER, A MID-STREAM CLEAN-CATCH SPECIMEN) DOES NOT HELP TO REDUCE FALSE POSITIVE UA OR URINE CULTURE RESULTS, AND THAT AS A RESULT, WIPES SHOULD NOT BE INCLUDED IN ANY OF OUR URINE COLLECTION KITS. NOT RECOMMENDING THE USE OF CLEANSING WIPES AND A MID-STREAM CLEAN CATCH SPECIMEN GOES AGAINST OUR IFU, AS WELL AS CLSI GUIDELINES AND RECOMMENDATIONS. LOT NUMBER: NON SPECIFIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898420 ↗
• InjuryJul 18, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE HAS BEEN NEEDLE STICK INJURIES WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364956, BATCH NO. UNKNOWN. IT WAS REPORTED THAT THERE HAS BEEN 3 ACCIDENTAL NEEDLE STICK INJURIES OCCURRED WITH URINE CUP, OVER A COURSE OF 5 YEARS. (2 OF 3: DATE OF EVENT (B)(6) 2017). WHEN I TRIED TO RUN MY REPORT AGAIN THE COMPUTER ONLY CAME UP WITH 3 IN THE LAST 5 YEARS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8804066 ↗
• InjuryJul 18, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED FROM THE BD VACUTAINER® URINE COMPLETE CUP KIT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE HAS BEEN 3 ACCIDENTAL NEEDLE STICK INJURIES OCCURRED WITH URINE CUP, OVER A COURSE OF 5 YEARS."

  Patient problems: Needle Stick/Puncture

  MAUDE report 8802884 ↗

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.