BD MiniDraw™ Finger Sleeve, Extra-Large 366616Recalls & reported problems
Becton, Dickinson And Company · BD MiniDraw™ Finger Sleeve, Extra-Large · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD MiniDraw finger sleeve is an extra-large sleeve used to collect small finger blood samples. The 25 reports mostly describe blood pooling or leftover blood in the sleeve, sometimes with leaking or splashing, with no deaths and no injuries. No recalls name this device. Reports dropped sharply in the most recent 12-month period compared with the prior period.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 30382903666165), received between Aug 6, 2024 and Oct 29, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (22 reports).
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
Most reported problems
Device problems
- Leak/Splash22
- Device Contamination with Body Fluid2
- Expiration Date Error1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 3 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS ONE INSTANCE OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411688 ↗MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 5 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS ONE INSTANCE OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411685 ↗MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 4 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS ONE INSTANCE OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411651 ↗MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS ONE INSTANCE OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410814 ↗MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 2: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, BLOOD WAS POOLING IN THE FINGER SLEEVE OF 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410812 ↗MalfunctionOct 29, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 2: IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN ONE DEVICE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410733 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN ONE DEVICE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21768248 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN ONE DEVICE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767167 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN ONE DEVICE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767166 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN THREE DEVICES. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767163 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN THREE DEVICES. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766187 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN ONE DEVICE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763620 ↗MalfunctionMar 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS RESIDUAL BLOOD IN TWO DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713789 ↗MalfunctionMar 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, BLOOD IS POOLING IN TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21643121 ↗MalfunctionMar 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WERE SIX (6) INSTANCES OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632961 ↗MalfunctionMar 10, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
REPORT 1 OF 2: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, BLOOD WAS POOLING IN THE FINGER SLEEVE OF 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559008 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547840 ↗MalfunctionMar 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING ON 3 UNITS. RECOLLECTION OF THE SAMPLE WAS COMPLETED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21538160 ↗MalfunctionMar 5, 2025Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526415 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING UNDER THE FINGERTIP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526413 ↗MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS SAMPLE LEAKAGE FROM ONE (1) TUBE. THE PATIENT PASSED OUT AT THE SIGHT OF THEIR BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21365247 ↗MalfunctionJan 7, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE SAMPLE WAS LEAKING OUT THE FRONT AND BACK OF ONE DEVICE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21094338 ↗MalfunctionDec 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE THERE WAS SAMPLE LEAKING FROM AN UNSPECIFIED NUMBER OF DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20884740 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS SAMPLE (BLOOD) POOLING WITHIN 12 DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793774 ↗MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED BEFORE USING THEBD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THE EXPIRATION DATE ON THE PACKAGING LABEL WAS BEYOND THE SPECIFIED PRODUCT SHELF LIFE. THE EVENT AFFECTED 3780 DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923816 ↗
Other Tubes, vacuum sample, with anticoagulant devices
- Vacuette 454322Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant3 recalls0 reports
- BD MiniDraw™ H&H Capillary Blood Collection Tube 366603Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant141 reports
- BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes 366643Becton, Dickinson U.K. Limited · Tubes, vacuum sample, with anticoagulant124 reports
- Cyto-Chex BCT 213559Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Cyto-Chex BCT 218980Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- BD MiniDraw™ Finger Sleeve, Large 366615Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant21 reports
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
- 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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