BD Vacutainer® Luer-Lok™ Access Device 36490200Recalls & reported problems
Becton, Dickinson And Company · BD LUER-LOK ACCESS DEVICE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Vacutainer Luer-Lok access device is used to draw blood into collection tubes. The 66 reports mostly describe blood and fluid leaking or splashing when the needle, tube or holder comes apart, plus some volume accuracy and packaging problems. None describe a death or an injury, and most note no effect on the patient or user. One open recall, started in January 2022, says the device can shed contaminant particles into urine samples that certain Sysmex analyzers misread as red blood cells, causing falsely high counts.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00382903649020), received between Nov 27, 2017 and May 20, 2026 — classified as 65 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jan 6, 2022Class IIIOpen, Classified
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
Z-0665-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak19
- Leak/Splash15
- Product Quality Problem4
- Volume Accuracy Problem4
- Difficult to Insert3
- Separation Problem3
- Short Fill3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Known Impact Or Consequence To Patient6
- Exposure to Body Fluids4
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD LUER LOK ACCESS DEVICE, THE NEEDLE AND HOLDER SEPARATED AN UNSPECIFIED NUMBER OF TIMES WITH AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234392 ↗MalfunctionMar 26, 2026Unsealed Device Packaging
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE PACKAGING OF FIVE DEVICES WAS NOT PERFORATED AT THE CONNECTION POINT RESULTING IN OPEN PACKAGES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700314 ↗MalfunctionJan 21, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE TUBE DETACHED FROM THE DEVICE RESULTING IN A SUDDEN SPRAY OF BLOOD. THIS OCCURRED ONE TIME. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24133375 ↗MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE NEEDLE SLEEVE OF TWO DEVICES FAILED TO RETRACT CAUSING BLOOD TO DRIP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358868 ↗MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, SAMPLE LEAKAGE WAS SEEN WITH ONE DEVICE RESULTING IN BLOOD DRIPPING ONTO THE PATIENT, THE NURSE, THE CHAIR, AND THE FLOOR. THE NURSE WAS WEARING GLOVES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998297 ↗MalfunctionJul 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, NAVY FOREIGN MATTER WAS SEEN INSIDE THE HUB OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375412 ↗MalfunctionJun 20, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, ONE DEVICE WAS UNABLE TO DRAW BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301616 ↗MalfunctionJun 11, 2025Fluid/Blood Leak; Difficult to Insert; Fluid/Blood Leak; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER, TUBE PUSH OFF IS SEEN IN AN UNSPECIFIED NUMBER OF DEVICES RESULTING IN SAMPLE LEAKAGE AND BLOOD EXPOSURE. IT IS UNCLEAR THE LEVEL OF PPE WORN BY THE HEALTHCARE WORKER NOR IF THERE WAS MEDICAL INTERVENTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions
MAUDE report 22183857 ↗MalfunctionJun 10, 2025Fluid/Blood Leak; Difficult to Insert; Fluid/Blood Leak; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER, TUBE PUSH OFF IS SEEN IN AN UNSPECIFIED NUMBER OF DEVICES RESULTING IN SAMPLE LEAKAGE AND BLOOD EXPOSURE. IT IS UNCLEAR THE LEVEL OF PPE WORN BY THE HEALTHCARE WORKER NOR IF THERE WAS MEDICAL INTERVENTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Exposure to Body Fluids
MAUDE report 22176171 ↗MalfunctionJun 10, 2025Fluid/Blood Leak; Difficult to Insert; Fluid/Blood Leak; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER, TUBE PUSH OFF IS SEEN IN AN UNSPECIFIED NUMBER OF DEVICES RESULTING IN SAMPLE LEAKAGE AND BLOOD EXPOSURE. IT IS UNCLEAR THE LEVEL OF PPE WORN BY THE HEALTHCARE WORKER NOR IF THERE WAS MEDICAL INTERVENTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Exposure to Body Fluids
MAUDE report 22176170 ↗MalfunctionMay 30, 2025Leak/Splash; Short Fill; Improper Chemical Reaction; Leak/Splash; Short Fill; Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER, THE HUB OF AN UNSPECIFIED NUMBER OF DEVICES DOES NOT SCREW ON CORRECTLY RESULTING IN SAMPLE LEAKAGE, LOSS OF VACUUM AND HEMOLYSIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119566 ↗MalfunctionApr 25, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, BLOOD STOPPED FLOWING WHEN ATTEMPTING TO COLLECT BLOOD FROM AN IV. ONE (1) DEVICE WAS AFFECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21912722 ↗MalfunctionApr 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE HOLDER OF ONE (1) DEVICE BROKE AT THE LUER ACCESS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775376 ↗MalfunctionMar 21, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, INSUFFICIENT BLOOD FLOW WAS SEEN WITH TWO (2) ADAPTERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21664903 ↗MalfunctionMar 14, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, HEMOLYSIS WAS SEEN IN BOTH GREEN AND PINK TOP TUBES. EXACT TUBES USED IS UNKNOWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606459 ↗MalfunctionFeb 10, 2025Separation Problem; Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE TIP OF ONE DEVICE BROKE OFF INSIDE OF THE HUB. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344967 ↗MalfunctionJan 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THERE WAS SAMPLE LEAKAGE WHEN BLOOD CULTURE BOTTLES WERE REMOVED. AN UNSPECIFIED NUMBER OF DEVICES WERE AFFECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21265065 ↗MalfunctionJul 2, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE, THE NEEDLE WAS UNABLE TO BE REMOVED. THE PATIENT HAD TO BE REINJECTED FOR TREATMENT TO BE ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656763 ↗MalfunctionJul 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE THERE WAS LEAKAGE FROM THE NON-PATIENT CANNULA. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651432 ↗MalfunctionJun 20, 2024Break; Break
IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER, THE NON-PATIENT NEEDLE PULLED LOOSE AND GOT STUCK IN THE COLLECTION TUBE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19579678 ↗MalfunctionJun 14, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE THE SLEEVE FAILED TO RETRACT CAUSING BLOOD TO LEAK. . THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536456 ↗MalfunctionJun 4, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER THE SHEATH AROUND THE NEEDLE WAS DEFECTIVE CAUSING BLOOD SAMPLE LEAKAGE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458582 ↗MalfunctionMay 22, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE, AN UNSPECIFIED NUMBER OF BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTERS FAILED TO RETRACT, LEADING TO BLOOD LEAKAGE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19378295 ↗MalfunctionApr 24, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT WHILE USING THE BD LUER-LOK ACCESS DEVICE, IT WAS DIFFICULT TO REMOVE THE DEVICE FROM THE CONNECTED IV LINE. NO PATIENT IMPACT REPORTED.REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169947 ↗MalfunctionApr 24, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT WHILE USING THE BD LUER-LOK ACCESS DEVICE, IT WAS DIFFICULT TO REMOVE THE DEVICE FROM THE CONNECTED IV LINE. NO PATIENT IMPACT REPORTED. REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169907 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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