BD QUINCKE Spinal Needles 405081Recalls & reported problems
Becton, Dickinson And Company · NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE · Class 2
All models of BD QUINCKE Spinal Needles (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382904050818), received between Aug 25, 2022 and Sep 7, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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/Splash5
- Break1
- Material Discolored1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658100 ↗MalfunctionSep 7, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657661 ↗MalfunctionJul 27, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035899 ↗MalfunctionJan 12, 2026Product Quality Problem
IT IS REPORTED NEEDLE HAD PROTRUDED BEYOND THE SHEATH. INITIAL DESCRIPTION: THE DOCTOR UPON OPENING THE SPINAL NEEDLE PACKAGE, IT WAS FOUND THAT THE NEEDLE HAD PROTRUDED BEYOND THE SHEATH, AND IT HAD NOT BEEN USED YET. THE NEEDLE WAS INSIDE THE SHEATH WITHIN THE PACKAGING FROM THE BEGINNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24035873 ↗MalfunctionMay 16, 2024Leak/Splash; Leak/Splash
D SPINAL NEEDLE 27G(CAT NO.405081) LOT: 3100744 EXP.: 3/31/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT BD SPINAL NEEDLE 27G (CAT NO. 405081) LOT 3286308 EXP.9/30/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT. STOP USING THESE LOT NO. CHANGE LOT NO. TO CUSTOMER FOR TRIAL. ADDITIONAL INFORMATION: NO HARM TO PATIENT OR CAREGIVER. 3. THE REPORT INCIDENT NOTICED DURING USE. 4. CSF FLUID LEAK OUT DURING CHANGE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19329751 ↗MalfunctionDec 15, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE PROCEDURE BLOCK THE PATIENT'S BACK WITH SPINAL 27G AND CONTINUE THE SYRINGE TO INJECT DRUG THE PATIENT. FOUND THAT THE DRUG WAS DRIPPING DIRECTLY BETWEEN THE NEEDLE JOINT AND THE SYRINGE (HUB).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15988362 ↗MalfunctionDec 15, 2022Material Discolored; Material Discolored
IT WAS REPORTED THAT THE BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL EXPERIENCED INCORRECT COLOR ON THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COLOR OF HUB HAS A DARK GREY WHICH IS USUALLY LIGHT GRAY. THE NUMBER OF CASES FOUND 1 BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15988149 ↗InjuryAug 25, 2022Break; Break
IT WAS REPORTED THAT WHILE USING THE BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL THE NEEDLE WAS DAMAGED DURING OPERATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPINAL NEEDLE (SKU 405081) HAS BEEN DAMAGED DURING OPERATION. DESCRIBE PATIENT / HCP / USER IMPACT: UNIDENTIFIED OBJECT (SMALL PIECE) WERE FOUND BY X-RAY IN PATIENT'S BODY BUT NO ADDITIONAL TREATMENT FROM SURGEON.
Patient problems: Foreign Body In Patient
MAUDE report 15298377 ↗
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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
- 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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