BD® Quincke Spinal Needles 405211Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382904052119), received between Sep 24, 2018 and Aug 27, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Break; Break

  MATERIAL # 405211. BATCH # 4045038. IT WAS REPORTED BY CUSTOMER THAT NEEDLE BREAKING OFF INSIDE OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REP XXXXXX EMAILED TO REPORT PRODUCT B-D405211Z BREAKING OFF INSIDE OF HUB. CUSTOMER IS REQUESTING CREDIT FOR 1 BX OF ITEM.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20075042 ↗
• InjuryJun 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD¿ LONG LENGTH SPINAL NEEDLE WITH QUINCKE BEVEL A CSF LEAK OCCURED IN A PATIENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: NOW I HAVE A QUESTION ON ANOTHER TOPIC. LAST WEEK, ON THE OCCASION OF AN EPIDURAL STEROID INFILTRATION, WE HAD A COMPLICATION OF A CSF LEAK IN A PATIENT. WE USE THE BD QUINCKE NEEDLE FOR THIS. IN THE GUIDELINES, YOU ALWAYS READ ABOUT "ATRAUMATIC" NEEDLES, FOR BD, FOR EXAMPLE, THE WHITECARE. WHEN I LOOK AT THE NEEDLES, HOWEVER, I WOULD ASSUME THAT THIS IS A NEEDLE EXCLUSIVELY FOR CSF PUNCTURE. CAN THESE NEEDLES ALSO BE USED FOR EPIDURAL INFILTRATION? THE OPENING IN FRONT OF THE TIP DOES NOT SEEM SUITABLE TO ME. OR ARE THERE OTHER "ATRAUMATIC" NEEDLES FOR EPIDURAL INFILTRATIONS? UPDATE 20JUN2023: 1. WAS THERE ANY PATIENT IMPACT/HARM DUE TO THE CSF LEAK? YES, A CSF LOSS SYNDROME, THE PATIENT HAD A HEADACHE, COULD ONLY LIE DOWN AND COULD NOT GO TO WORK FOR 2 WEEKS. 2. HAS A SPECIAL TREATMENT/SAFETY MEASURE BEEN IMPLEMENTED? YES, A BLOOD PATCH EPIDURAL. THANK YOU IN ADVANCE FOR YOUR SUPPORT.

  Patient problems: Headache

  MAUDE report 17240611 ↗
• MalfunctionMar 25, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE SPINAL S/SU 20GA 6IN QUINCKE HUB BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC NEEDLE HUB BROKEN SO NEEDLE WOULDN'T REMAIN LOCKED FOR INSERTION. THE PLASTIC NEEDLE HUB HAS BROKEN SO THE NEEDLE WOULDN'T REMAIN LOCKED FOR INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573089 ↗
• MalfunctionFeb 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE SPINAL S/SU 20GA 6IN QUINCKE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIDDEN DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11269741 ↗
• MalfunctionSep 24, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USE OF THE BD¿ QUINCKE 20 GAUGE 6 INCH LONG SPINAL NEEDLE, THERE WAS NO LABEL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903625 ↗