BD MiniDraw™ Finger Sleeve, Large 366615Recalls & reported problems
Becton, Dickinson And Company · BD MiniDraw™ Finger Sleeve, Large · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30382903666158), received between Nov 27, 2024 and Oct 24, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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/Splash21
- Device Contamination with Body Fluid1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 3 OF 5. IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, 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 23380628 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 5 IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, 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 23380626 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 4 OF 5 IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, 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 23380625 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 5 OF 5. IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, 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 23380612 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 3 OF 3. IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS RESIDUAL BLOOD POOLING IN 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378984 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 3. IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS RESIDUAL BLOOD 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 23378969 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS 1 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 23378852 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 3 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS 1 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 23378851 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 4 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS 1 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 23378850 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
REPORT 5 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS 1 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 23378813 ↗MalfunctionMar 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE THERE WAS RESIDUAL BLOOD IN SIX DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21723989 ↗MalfunctionMar 21, 2025Leak/Splash; Leak/Splash
REPORT 1 OF 4. IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS RESIDUAL BLOOD POOLING IN THE FINGER SLEEVE OF 2 UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662640 ↗MalfunctionMar 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WERE FIVE (5) 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 21652374 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, LARGE, BLOOD WAS 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 21572303 ↗MalfunctionMar 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE IS BLOOD SMEARING ON THE SIDE OF THE FINGER AND IN THE LANCING PORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537854 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, 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 21529824 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING ON THE SIDE OF THE FINGER AND IN THE LANCING PORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526760 ↗MalfunctionFeb 25, 2025Leak/Splash; Device Contamination with Body Fluid; Leak/Splash; Device Contamination with Body Fluid
IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, LARGE, BLOOD DRIPPED OUT THROUGH THE FRONT OF THE SLEEVE AFTER POOLING AT THE TOP OF THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459572 ↗MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS SAMPLE LEAKAGE FROM ONE (1) TUBE. THE PATIENT PASSING OUT AT THE SIGHT OF BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376066 ↗MalfunctionDec 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, 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 20881497 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE, THERE WAS SAMPLE (BLOOD) POOLING WITHIN 5 DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793067 ↗
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, Extra-Large 366616Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant25 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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