BD Vacutainer® Sodium Fluoride 30mg Blood Collection Tubes 367729Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382903677291), received between May 31, 2018 and Jan 29, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K901449); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE IT WAS DISCOVERED THAT THE VACUTAINER WAS CRACKED WITH A BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED A CRACK LIP ON VACUTAINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9642749 ↗
• MalfunctionDec 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT STOPPER REMOVAL OCCURRED DURING USE WITH A BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE 2ND TIME STOPPER REMOVAL FORCES DOES NOT MEET THE MEAN FORCE SPECIFICATION. (B)(4) OF (B)(4) : ITEM 367729 DURING R&D TESTING IN FRANKLIN LAKES, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. 14-NOV: RCVD AN EMAIL FROM THE CUSTOMER PROVIDING THE FOLLOWING INFORMATION: - ARE SAMPLES AVAILABLE FOR INVESTIGATION? ¿ UNFORTUNATELY, I CAN¿T SUPPLY SAMPLES FOR THE INVESTIGATION - WHEN IS THE STOPPER COMING OUT? ¿ THE TUBES WERE EVALUATED AFTER THE STOPPER WAS RE-INSERTED INTO THE TUBE. THE STOPPERS DID NOT COME OUT OF THE TUBE ON THEIR OWN (THEY CAME OUT WHEN THE TEST FIXTURE MEASURED THE FORCE TO REMOVE THE RE-INSERTED STOPPER) - WAS A HOLDER USED? WAS IT A BD HOLDER? ¿ TUBES WERE FILLED WITH WATER USING A BD LLAD 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 - NO - WAS THE CLOSURE R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397428 ↗
• MalfunctionOct 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES STOPPER DID NOT MEET FORCE SPECIFICATIONS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367729. BATCH NO: 9184898. IT WAS REPORTED THAT DURING BD R&D TESTING, THE TUBES WERE OBSERVED WITH SECOND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM FORCE SPECIFICATION. EVENT DESCRIPTION PER EMAIL STATES: DURING R&D TESTING, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM FORCE SPECIFICATION. WE ALSO OBSERVED 1 BATCH OF TUBES THAT DID NOT MEET THE MEAN FORCE SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9251235 ↗
• InjuryAug 19, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES EXPERIENCED A CRACKED TUBE WITH THE TUBE SHATTERING PRIOR TO USE. DEVICE OPERATOR REQUIRED STITCHES AS A RESULT OF THE TUBE SHATTERING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367729 BATCH NO. 8303642. CUSTOMER STATED - THE TUBE SHATTERED IN ONE OF THE LAB TECHS HAND AND THEY WERE HURT. THEY OPENED THE WHOLE CASE AND FOUND CRACKS IN THE TUBES. CUSTOMER CONFIRMED THAT THE LAB RECEIVED 2 CASES OF GREY TOP TUBES. THE PATHOLOGY ASSISTANT USED SEVERAL TUBES OUT OF THE PACKAGE AND WHEN SHE PULLED THE TOP OFF OF ONE IT SHATTERED IN HER HAND. SHE HAD TO GET STITCHES IN HER HAND, AND WILL BE OUT OF THE OFFICE UNTIL THE BEGINNING OF NEXT WEEK. THE LAB OPENED UP OTHER PACKAGES IN THE CASES AND FOUND AT LEAST 1 TUBE WITH A CRACK. DUE TO THE INJURY, ALL DAMAGED PRODUCT WAS DISPOSED BECAUSE IT WAS NOT APPROVED FOR USE AND PHOTOS CANNOT BE PROVIDED. SEVERAL EMPLOYEES WITNESSED THE INCIDENT. THERE IS CURRENTLY 1 OPEN PACKAGE WITHIN THE CASE. THE CUSTOMER STATED THIS HAS NEVER HAPPENED IN THE PAST.

  Patient problems: Laceration(s)

  MAUDE report 8905413 ↗
• MalfunctionMay 31, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES WERE HAVING ISSUES WITH HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901449. One submission often covers many models, so check the product and lot details in each record.

• Z-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
• Z-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
• Z-2297-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667