BD Vacutainer® Blood Transfer Device Holder 364880Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 50382903648806), received between Nov 27, 2017 and Jan 14, 2026 — classified as 2 injuries, 184 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (50 reports).

4 other recalls cover devices cleared under the same FDA submission (K991088); 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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING SAMPLE COLLECTION USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THE VACUTAINER TUBE SLIPPED OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068591 ↗
• MalfunctionJan 7, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, 2 DEVICES WERE UNABLE TO SUCTION BLOOD INTO THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995960 ↗
• MalfunctionMay 8, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD TRANSFER DEVICE, DISPENSING SPEED IS SLOW FOR AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988066 ↗
• MalfunctionNov 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER THERE WAS BLACK DOT FOREIGN MATTER ON THE PRODUCT. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777432 ↗
• MalfunctionApr 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THAT THE NON-PATIENT SLEEVE DETACHED FROM THE DEVICE CAUSING BLOOD LEAKAGE. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172888 ↗
• MalfunctionFeb 14, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER WAS NOT FILLING BLOOD COLLECTION TUBES PROPERLY. THERE WAS INSUFFICIENT BLOOD FLOW. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704031 ↗
• MalfunctionJan 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER, IT WAS NOTICED THAT 4 BOXES ARRIVED WITHOUT A PRODUCT LABEL AND BARCODE LABEL AFFIXED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18487508 ↗
• MalfunctionJan 8, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT WHILE USING BD BLOOD TRANSFER DEVICE, THE RUBBER SLEEVE INSIDE CAME OFF. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469803 ↗
• MalfunctionNov 8, 2023Premature Separation; Premature Separation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THAT SINGLE RUBBER SLEEVE CAME OFF DURING DISPENSING CAUSING A FAILURE OF THE DEVICE. THERE IS NO CLAIM OF PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094422 ↗
• MalfunctionOct 24, 2023Short Fill; Premature Separation; Short Fill; Premature Separation

  IT WAS REPORTED THAT DURING USE WITH BD BLOOD TRANSFER DEVICE THE TUBE WAS UNABLE TO FILL FULLY AND THE SLEEVE SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT BLOOD WAS DISPENSED INTO TWO BLOOD COLLECTION TUBES. THE FIRST TUBE WAS ABLE TO DISPENSE BLOOD NORMALLY, BUT BLOOD DID NOT FLOW INTO THE SECOND TUBE. SINCE THE BLOOD HAD NOT CLOTTED IN THE SYRINGE, AN ATTEMPT WAS MADE TO DISPENSE IT AGAIN, BUT NO BLOOD FLOWED IN. WHEN THE BLOOD COLLECTION TUBE WAS REMOVED FROM THE BTD, THE RUBBER SLEEVE CAME OFF ALONG WITH THE BLOOD COLLECTION TUBE. THE BLOOD COLLECTION TUBE TO WHICH IT WAS DISPENSED HAS ALREADY BEEN DISCARDED. THE PATIENT IS HTLV POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999443 ↗
• MalfunctionOct 18, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® BLOOD TRANSFER DEVICE THE LABEL WAS MISSING FROM THE SHELF PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT NO LABEL WAS ATTACHED. THIS LABEL WAS MISSING FOR THE SHELF PACKAGE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958425 ↗
• MalfunctionOct 10, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER, THE SLEEVE CAME OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE CUSTOMER REPORTED THAT THE RUBBER SLEEVE ON THE NP NEEDLE CAME OFF. THE RUBBER SLEEVE CAME OFF DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909531 ↗
• MalfunctionAug 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER CUSTOMER REPORTS THAT THE RUBBER SLEEVE WAS STUCK DURING BLOOD COLLECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER SLEEVE WAS STUCK IN THE BLOOD COLLECTION TUBE AND FELL OUT, CAUSING BLOOD LEAKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620725 ↗
• MalfunctionAug 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER DIRT WAS FOUND IN POLYBAG. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT FM DIRT. FM DIRT WAS IN THE POLYBAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515400 ↗
• MalfunctionJul 17, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THAT THE SLEEVE FALLS OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE RUBBER SLEEVE CAME OFF AND FELL INTO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332241 ↗
• MalfunctionJul 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER CUSTOMER FOUND A FOREIGN MATTER ON TOP OF THE OPENING AND THE SYRINGE COULD NOT BE INSERTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S REPORT, THERE WAS FM AT THE TOP OPENING AND A SYRINGE COULD NOT BE INSERTED. A SUBSTITUTE PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298313 ↗
• MalfunctionJul 10, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THAT THERE WAS NEEDLE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE NEEDLE CAME APART AND FELL INTO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294908 ↗
• MalfunctionJun 12, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THE RUBBER SLEEVE WAS SEPARATED WHEN REMOVING THE TUBE. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS IS A REPORT ABOUT SLEEVE SEPARATION IN USAGE WITH TERUMO'S TUBES. ACCORDING TO THE CUSTOMER'S REPORT, THE RUBBER SLEEVE WAS SEPARATED WHEN REMOVING THE TUBE. THIS ISSUE HAS OCCURRED TWICE IN A ROW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109200 ↗
• MalfunctionJun 6, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USAGE, THE NP NEEDLE WAS FOUND TO HAVE PIERCED THE SIDE OF THE SLEEVE. WHETHER IT PIERCED BEFORE USAGE OR DURING USE IS UNKNOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074379 ↗
• MalfunctionJun 2, 2023Missing Information; Missing Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE OUTSIDE CASE LABEL WAS MISSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054582 ↗
• MalfunctionMay 24, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS A POOR SLEEVE FUNCTION ISSUE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE BLACK RUBBER PART WAS SEPARATED, TRAPPED WITH A TUBE. THIS ISSUE OCCURRED ABOUT THREE TIMES.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994365 ↗
• MalfunctionApr 26, 2023Filling Problem; Filling Problem

  IT WAS REPORTED THAT WHILE USING THE BLOOD TRANSFER DEVICE THAT TTHE TUBE WAS NOT ABLE TO FILL COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, WHEN DISPENSING BLOOD, AIR ENTERS RESULTING IN AN INSUFFICIENT VOLUME OF BLOOD DRAWN BY THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820346 ↗
• InjuryApr 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD TRANSFER DEVICE "EXPLODED", HCP GOT BLOOD IN EYES, MOUTH, FACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16698886 ↗
• MalfunctionApr 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLACK PARTICLES WERE FOUND IN A PACKAGE OF BTD UPON ARRIVAL AT THE DISTRIBUTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691174 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING BLOOD TRANSFER INTO TERUMO'S TUBE (EDTA2NA) BY USING BTD, THE FILM STOPPER OF THE TERUMO'S TUBE WAS BROKEN AND BLOOD LEAKED FROM IT. THE HCP MAY HAVE PRESSED THE TUBE STRONGLY WHEN USING THE BTD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991088. One submission often covers many models, so check the product and lot details in each record.

• Z-0837-2022 · Feb 24, 2022 · Terminated
  Regard Custom Procedure Kits containing BD Luer Lok Access Devices
• Z-0665-2022 · Jan 6, 2022 · Open, Classified
  BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during bloo
• Z-0253-2007 · Sep 8, 2006 · Terminated
  BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes,
• Z-1462-06 · Jun 21, 2006 · Terminated
  BD Vacutainer Luer Adapter; Catalog #367290 and #367300.