BD Vacutainer® Buff. Na Citrate (9NC) 369714Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 50382903697149), received between Oct 30, 2017 and Sep 5, 2023 — classified as 2 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Break” (32 reports).

1 FDA recall record name this device's identifier.

9 other recalls cover devices cleared under the same FDA submission (K945952); 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.

Recalls naming this device

1. Mar 16, 2017Class IITerminated

   BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

   Z-1746-2017 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ESR BLOOD COLLECTION TUBES THE BOTTOM OF THE TUBE WAS BROKEN AND BLOOD LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: STAGE: DURING BLOOD COLLECTION AND USE DEFECT: BLOOD COLLECTION TUBE HAS NO BOTTOM AND BLOOD LEAKAGE QUANTITY: 1 PIECE. EFFECTS: NO OTHER ADVERSE EFFECTS ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687005 ↗
• MalfunctionSep 15, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCE UNDERFILLING TUBES WHEN THEY ARE ABOUT TO EXPIRE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT TUBES ARE UNDERFILLING AND IT IS "NORMAL" FOR THEM TO EXPERIENCE UNDERFILLING TUBES WHEN THEY ARE ABOUT TO EXPIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433384 ↗
• MalfunctionMar 24, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED "THE CITRATE TUBES DO NOT HAVE ANY ADDITIVE IN THEM. CUSTOMER STATES THEY CANNOT USE THE CITRATE TUBES BECAUSE THEY DO NOT HAVE ANY ADDITIVE. MULTIPLE TUBES WERE MISSING ADDITIVES AND OTHERS DID NOT HAVE THE SAME AMOUNT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563621 ↗
• MalfunctionMar 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THERE WAS STOPPER POPPING OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED: "A PROBLEM HAS BEEN REPORTED REGARDING THE USE OF "BLUE" VENIPUNCTURE TUBES, IE BD VACUTAINER. ON A FEW OCCASIONS THE CAP DETACHED FROM THE TUBE DURING THE SAMPLING, CAUSING BLOOD TO SPILL INTO THE BARREL WHICH IMPACTED THE COLLECTION PROCESS AND CAUSED RISK TO USERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544125 ↗
• MalfunctionMar 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED STOPPER POPS OUT OF THE TUBE. THE EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE ISSUE IS THAT THE TOP IS COMING OFF THE BLOOD VIAL VACUTAINER WHEN THE CLINICAL STAFF IS PULLING IT OFF FROM THE VACUTAINER HOLDER. WE ARE ONLY HAVING THIS ISSUE WITH THE BLUE TOPS- NONE OF THE OTHER BLOOD TUBES HAVE HAD THIS ISSUE. I HAVE THE BLOOD TUBE FROM THE LAST REPORTED INCIDENT IN A BIOHAZARD BAG IF BD NEEDS IT FOR REVIEW." ADDITIONAL INFORMATION: 2/24/2021. WAS THERE ANY BLOOD EXPOSURE TO THE MOUTH OR EYE, IF SO PLEASE PROVIDE DETAILS.- NO DID ANY PATIENTS HAVE TO BE REDRAWN, IF SO HOW MANY AND ON WHAT DATES?- YES, TWO WAS THERE ANY MEDICAL INTERVENTION, IF SO PLEASE PROVIDE DETAILS.- NO DO YOU HAVE ANY UNUSED SAMPLES AVAILABLE FOR THE INVESTIGATION?- HAVE BOTH A USED SAMPLE IN A BIOHAZARD BAG AND UNUSED PRODUCT THAT WAS PULLED FROM THE SHELVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455022 ↗
• MalfunctionFeb 12, 2021Short Fill; Volume Accuracy Problem; Device Markings/Labelling Problem; Short Fill; Volume Accuracy Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE USER REPORTED UNDERFILLING OR LOW DRAW OF TWO TUBES AND MISSING LABEL ALONG WITH MISSING OR NO LABEL INFORMATION. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "CUSTOMER QUESTIONS ABOUT THE CORRECT WAY TO COLLECT IN THE 4.5 ML CITRATE TUBE, AS IT DOES NOT HAVE A MARK INDICATING HOW FAR IT CAN BE COLLECTED. SHE REPORTED IN THIS QUESTIONING THAT WHEN THEY PERFORM VACUUM COLLECTION, THE TUBE FILLS ONLY 20%, AROUND 2 ML."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11322668 ↗
• MalfunctionJan 8, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES WERE FOUND WITH MISSING ADDITIVE. THIS EVENT OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBES ARE MISSING THE ADDITIVE CAUSING THE TUBE TO CLOTTING. SHE INFORMED ME THAT THEY ARE HAVING AN ISSUE WITH THEIR SODIUM CITRATE TUBE (CAT 369714). THERE IS NO LIQUID ADDITIVE IN THE TUBE AND SPECIMENS ARE CLOTTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11142227 ↗
• MalfunctionDec 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THERE WAS POOR BARRIER SEPARATION AND SAMPLE WAS HEMOLYZED. CUSTOMER STATED THEY ARE USING TUBES FOR PRP FACIALS AND THEREFORE BEING USED OFF LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED POOR BARRIER SEPARATION. INFORMED CUSTOMER THAT USING THE TUBES FOR PRP IS OFF LABEL AND THAT THEY ARE NOT DESIGNED TO BE REINJECTED BACK INTO THE PATIENT. SHE DREW BLOOD FROM A HEALTHY YOUNG MALE USING A 23G BUTTERFLY NEEDLE, DREW 3 TUBES AND IMMEDIATELY SPUN DOWN FOR 12 MINUTES. SHE STATES THAT THE TOP PART WHERE THE PLASMA SHOULD BE WAS RED AND THAT ANOTHER TUBE WAS MORE PINK AT TOP, SAID THAT THIS SOUNDS LIKE THE SAMPLE WAS HEMOLYZED. SHE STATES TUBES WERE NOT EXPIRED AND DREW FINE. SHE HAS NEVER HAD THIS HAPPEN BEFORE. SHE CURRENTLY DOES NOT HAVE THE LOT#.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11097524 ↗
• MalfunctionNov 19, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE TUBES HAD A LOW. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THREE BLOOD COLLECTION TUBES DID NOT FILL COMPLETELY. DID ANY PATIENTS HAVE TO BE REDRAWN? BECAUSE THESE TUBES WERE DRAWN IN THE OUTPATIENT AREA, STAFF WERE ABLE TO GRAB ANOTHER TUBE IMMEDIATELY DURING THE COLLECTION SO REDRAWS WERE NOT REQUIRED FOR ANY OF THE 3 PATIENTS. WAS THERE ANY MEDICAL INTERVENTION, IF PLEASE PROVIDE THE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10869034 ↗
• MalfunctionOct 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE STOPPER PULLED OUT OF TUBE WITHIN HOLDER AND BLOOD LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A BLOOD DRAW ON SITE FOR THE INTERNAL COLLECTION PROGRAM, A NA CITRATE VACUTAINER BLUE TOP BECAME LODGED IN THE VACUTAINER HOLDER AND ON THE NEEDLE. BLOOD DID LEAK OUT OF DEVICE AND ONLY THE DONOR AND PHLEBOTOMIST WAS PRESENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706440 ↗
• MalfunctionOct 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THEY ARE EXPERIENCING ERRONEOUS RESULTS. THE SITES ARE HAVING PT APTT AND INR EVALUATION ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 10667619 ↗
• MalfunctionOct 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THEY EXPERIENCED ERRONEOUS RESULTS. THE SITES ARE HAVING PT APTT AND INR EVALUATION ISSUES. ADDITIONAL INFORMATION: CUSTOMER STATES "AT PRESENT, WE HAVE SCREENED 159 SUBJECTS INTO THIS TRIAL AND HAVE NEVER ENCOUNTERED THESE ISSUES. I CAN ASSURE YOU, AFTER CONFIRMATION WITH OUR LAB TECHNICIANS, THERE WERE NO OUTSTANDING ISSUES OF CONCERN WITH THESE LAB COLLECTIONS AND BLOOD FLOW WAS NORMAL. COLLECTION AND PROCESSING OF THESE SAMPLES WERE ALL COMPLETED AS REQUIRED BY PROTOCOL AND LAB MANUAL SPECIMEN COLLECTION GUIDELINES. I CAN CONFIRM THAT OUR STAFF HAS REMAINED CONSISTENT THROUGHOUT THIS TRIAL, AS THERE HAVE BEEN NO STAFF CHANGES. THE ONLY ISSUE I CAN THINK OF THAT IS BEYOND OUR CONTROL IS THE TRANSPORT OF SAMPLES AND ULTIMATELY THEIR STABILITY ONCE ANALYZED."

  Patient problems: No Patient Involvement

  MAUDE report 10667608 ↗
• MalfunctionOct 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THEY ARE "HAVING THE SAME ISSUE WITH ELEVATED INR'S ON NORMAL SUBJECTS." NEW INFORMATION: CUSTOMER STATES "HAVING ONE MORE SITE COMPLAINING OF THIS SAME ISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639613 ↗
• MalfunctionSep 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBE HAS A BROWN STAIN IN THE TUBE. THE UPPER TUBE HAS A BROWN STAIN (LOWER IS NORMAL TUBE) AND SITE SUSPECT IT MAY BE CONTAMINATED. COULD YOU SEND THE PICTURE FOR VENDOR AND LET THEM EXPLAIN WHETHER IF THIS TUBE CAN BE USE? AND WHY? THE CATALOG NO. IS 369714, LOT NO. IS 9344028."

  Patient problems: No Patient Involvement

  MAUDE report 10569834 ↗
• MalfunctionSep 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES REPORTED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ADDITIONAL SITES ARE HAVING THE SAME ISSUE WITH ELEVATED INR'S OR NORMAL SUBJECTS. PER EMAIL: I HAVE ADDITIONAL SITES USING LOT NUMBERS 9184008 AND 9315472 THAT ARE HAVING THE SAME ISSUES WITH ELEVATED INR'S ON NORMAL SUBJECTS. SEND THE SAMPLES TO A LOCAL LAB USING A DIFFERENT LOT NUMBER AND RESULTS ARE FINE. (THE ORIGINAL COMPLAINT IS PR (B)(4)). "

  Patient problems: No Patient Involvement

  MAUDE report 10564233 ↗
• MalfunctionSep 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES REPORTED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ADDITIONAL SITES ARE HAVING THE SAME ISSUE WITH ELEVATED INR'S OR NORMAL SUBJECTS. PER EMAIL: I HAVE ADDITIONAL SITES USING LOT NUMBERS 9184008 AND 9315472 THAT ARE HAVING THE SAME ISSUES WITH ELEVATED INR'S ON NORMAL SUBJECTS. SEND THE SAMPLES TO A LOCAL LAB USING A DIFFERENT LOT NUMBER AND RESULTS ARE FINE. (THE ORIGINAL COMPLAINT IS PR (B)(4), WO-(B)(4))."

  Patient problems: No Patient Involvement

  MAUDE report 10563934 ↗
• MalfunctionSep 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THERE WERE ELEVATED INR'S ON PATIENT SAMPLES. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 4 COMPLAINTS) IT WAS REPORTED THAT ADDITIONAL SITES ARE HAVING THE SAME ISSUE WITH ELEVATED INR'S OR NORMAL S.

  Patient problems: No Patient Involvement

  MAUDE report 10560906 ↗
• MalfunctionSep 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Short Fill; Volume Accuracy Problem; Overfill; Incorrect, Inadequate or Imprecise Result or Readings; Short Fill; Volume Accuracy Problem; Overfill

  IT WAS REPORTED THAT THERE WERE ERRONEOUS "ELEVATED" COAGULATION RESULTS, SOME TUBES ARE OVER FILLING AND SOME ARE UNDER FILLING WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 4 COMPLAINTS). NOT SURE WHERE TO START ON THIS BUT WE HAVE HAD 2 SITES THIS WEEK CALLING AND STATING THAT THEY ARE RECEIVING ELEVATED COAGULATION RESULTS. ONE SITE WENT SO FAR AS TO SAY THAT THEY ARE SEEING THAT THE TUBES DO NOT SEEM TO BE COLLECTING THE SAME AMOUNT OF BLOOD, THE SITE HAS OBSERVED THE TUBE WILL EITHER ALLOW TOO MUCH BLOOD SAMPLE OR NOT ENOUGH AND THIS COULD BE AFFECTING RESULTS. THESE SUBJECTS ARE SCREENING SUBJECTS SO DO NOT HAVE HAD ANY DRUG FROM THE STUDY AND ARE NOT PATIENTS THAT WOULD BE ON ANY KIND OF MEDICATION FOR COAGULATION ISSUES. WE HAVE HAD THESE ISSUES OFF AN ON OVER THE PAST FEW MONTHS AND DID NOT ATTRIBUTE IT TO THE TUBE BUT RATHER POSSIBLY A COLLECTION ISSUES, BUT NOW 2 SITES CALLING WITHIN THE LAST 2 DAYS ARE CALLING COMPLAINING ABOUT THE EXACT SAME ISSUE AND THEY HAVE REVIEWED HOW THEY ARE COLLECTING IT TO RULE THAT ISSUE OUT. THE LAB HAS REVIEWED ALL OF THEIR PROCESSES AND CH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488183 ↗
• MalfunctionSep 3, 2020Break; Break

  IT WAS REPORTED THAT DURING USE GLASS TUBES ARE BREAKING WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IN HANDLING THE TUBES ARE BREAKING VERY EASILY, WITH A RISK OF BIOLOGICAL ACCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488177 ↗
• MalfunctionAug 17, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT FORMATION OF FIBRINS OCCURRED AFTER USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DR. INFORMS OF RECURRENCES IN THE FORMATION OF FIBRINS IN THE 4.5ML CITRATE TUBE (369714), IN ADDITION TO THE DIFFICULTIES IN OBTAINING THE "MINIMUM CENTRIFUGED" IN OBTAINING PLATELETS, IN ORDER TO GENERATE THE MINIMUM VOLUME FOR ANALYSIS WITH THE SUPPORT (PARDINI), TAKING THE RE CENTRIFUGATION IN 03 TO 04 TIMES IN AVERAGE ROTATION OF 2900RPM. IN THIS CASE, THE SAMPLE INDICATED REFERS TO LOT 9126547, HOWEVER, THE DR. INFORMS THAT SHE ALWAYS FINDS PROBLEMS OF THIS NATURE IN BD TUBES AND DOES NOT FIND THE SAME PROBLEMS IN VACUETE TUBES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414613 ↗
• MalfunctionAug 11, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT 2 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES HAD CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLOT IN THE CITRATE TUBE. CLOT IN THE CITRATE TUBE (4.5 ML CITRATE GLASS TUBE)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394093 ↗
• MalfunctionJul 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPPER POPS OFF DURING USE WITH AN BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) THE NURSE INDICATED THAT ONCE BLOOD SPECIMEN COLLECTION WAS COMPLETE AND AS SHE WAS LABELING THE SPECIMENS THE CAP/LID SPONTANEOUSLY BLEW OFF. BLOOD ALL OVER THE TABLE. ADDITIONALLY, ON 2020-06-29 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: · DID THE COURSE OF TREATMENT CHANGE? YES¿ THE PATIENT HAD TO BE POKED AGAIN · WAS THERE ANY EXPOSURE TO BLOOD/BODILY FLUIDS DUE TO THE STOPPER POPPING OFF? BLOOD SPEWED ALL OVER THE NURSING STATION DESK. O WAS THERE ANY MEDICAL ATTENTION NEEDED? FOR EXAMPLE LAB TESTING OR ADMINISTRATION OF ANTIVIRALS? NO. · WAS A HOLDER USED? WAS IT A BD HOLDER? ALL PRODUCTS USED ARE BD. · WAS THE ACQUISITION DEVICE BD? NOT SURE WHAT YOU MEAN BY AN ACQUISITION DEVICE¿? · WHAT IS THE ACQUISITION DEVICE THAT WAS USED? NEVER HEARD A PRODUCT DESCRIBED AS AN ACQUISITION DEVICE¿. DO YOU MEAN A VENIPUNCTURE DEVICE? · WAS A SYRINGE USED TO FILL TUBES? WAS PLUNGER PUSHED TO BLOOD OR WAS THE VACUUM USED TO DRAW THE BLOOD INTO THE TUBE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10258549 ↗
• MalfunctionMar 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING USE THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES STOPPER WAS DIFFICULT TO REMOVE. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLES DID NOT MEET STOPPER PULL FORCE REQUIREMENTS AT 50% SHELF LIFE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904353 ↗
• MalfunctionMar 16, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BREAKAGE OCCURRED AFTER USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THIS OCCURRED ON 2 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED BREAKAGE WHEN USING VACUTAINERS. ADDITIONAL INFORMATION FROM CUSTOMER: WERE THE TUBES FROZEN? (NO), WAS THERE DAMAGE UPON RECEIPT? (THEY SHATTERED IN THE PNEUMATIC TUBE SYSTEM AFTER SPECIMEN COLLECTION) AND WHAT WAS THE TIME AND SPEED OF CENTRIFUGED? (NOT CENTRIFUGED).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836590 ↗
• MalfunctionMar 16, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TUBES BREAK DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS). THE BLUE TOP TUBES ARE BREAKING IN THE PNEUMATIC TUBE SYSTEM AND SPILLING BLOOD ALL OVER OTHER SPECIMENS AND WITHIN THE BAG. ADDITIONALLY, ON (B)(6) 2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WERE THE TUBES FROZEN? (NO), WAS THERE DAMAGE UPON RECEIPT? (THEY SHATTERED IN THE PNEUMATIC TUBE SYSTEM AFTER SPECIMEN COLLECTION) AND WHAT WAS THE TIME AND SPEED OF CENTRIFUGED? (NOT CENTRIFUGED).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9835303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945952. One submission often covers many models, so check the product and lot details in each record.

• Z-2302-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
• Z-2300-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
• Z-2308-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
• Z-2301-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
• Z-2304-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
• Z-2303-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
• Z-2305-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
• Z-1189-2017 · Jan 16, 2017 · Terminated
  BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an eva
• Z-0911-2013 · Mar 5, 2012 · Terminated
  BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used