BD QUINCKE Spinal Needles 405181Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382904051815), received between Dec 13, 2017 and Jan 2, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056125 ↗
• MalfunctionJan 2, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056118 ↗
• MalfunctionMar 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD® QUINCKE SPINAL NEEDLES LEAKAGE OCCURRED AT THE HUB. THE NEEDLE WAS REPLACED AND PATIENT HAD TO HAVE ADDITIONAL POKE, THUS RESULTING IN ADDITIONAL PAIN AND DISCOMFORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PATIENT PENG (PERICAPSULAR NERVE GROUP BLOCK) PERIPHERAL NERVE BLOCK, 22GX3.5IN SPINAL NEEDLE BEGAN LEAKING WHERE THE NEEDLE JOINS THE CLEAR HUB OF THE NEEDLE. IT WAS NOT A LOOSE CONNECTION AT THE LUER LOCK ABOVE WHERE THE NEEDLE IS SCREWED ONTO THE EXTENSION TUBING. ANESTHESIA HAD TO STOP NERVE BLOCK PROCEDURE, REPLACE THE NEEDLE, THEN POKE THE PATIENT AGAIN. AS A RESULT, PATIENT REPORTED DISCOMFORT WITH EACH POKE.

  Patient problems: Pain

  MAUDE report 16475485 ↗
• MalfunctionDec 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD® QUINCKE SPINAL NEEDLES HAD FOREIGN MATTER ON THE BEVEL SIDE OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A MARKING ON THE BEVEL SIDE OF THE SPINAL NEEDLE. THE PHYSICIAN FEELS THE PRODUCT IS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12963661 ↗
• MalfunctionMar 11, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD¿ QUINCKE SPINAL NEEDLE CLOGGED DURING USE WHILE PIERCING A SILICONE DIAPHRAGM, WITH THE SILICONE PLUGGING UP THE NEEDLE AND PREVENTING AN EQUAL EXCHANGE OF GASSES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE IS STRAIGHTFORWARD 1 INCH 21 GAUGE, IT'S THE LARGER NEEDLE I'M HAVING TROUBLE FIGURING OUT. WE USE THE TWO TO REPLACE THE HEADSPACE GASSES OF VIALS, SO THE LONGER NEEDLE IS THE VENT TUBE THAT GOES TO THE BOTTOM OF THE VIAL, WHILE THE SHORTER NEEDLE IS CONNECTED TO THE LARGE SYRINGE AND INJECTS THE NEW GAS. WE HAVE ISSUES WITH BOTH OF THEM CLOGGING, AS WE USE THEM TO PIERCE A SILICON DIAPHRAGM, AND AFTER SOME TIME THE SILICON PLUGS UP THE NEEDLE, PREVENTING AN EQUAL EXCHANGE OF GASSES. WE USED TO HAVE AN EVEN THINNER LONG NEEDLE THAT WAS CLOGGED THAT WE USED TO PUSH OUT THE SILICON PLUGS FROM THE VENT NEEDLE, BUT IT GOT THROWN OUT ACCIDENTALLY. WE USE A LUER-LOCK CONNECTION FOR THESE AS WELL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9819436 ↗
• MalfunctionAug 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD¿ QUINCKE SPINAL NEEDLE HAD FOREIGN MATTER IN THE PACKAGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I ALLOW MYSELF TO MAKE NOVELTY FOUND IN SPINAL NEEDLE NO 22 X 3.50 IN WHICH IN ITS STERILE PACKAGE HAS A HAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921236 ↗
• MalfunctionJul 11, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEFECTED CATHETER WAS FOUND BEFORE USE WITH A NEEDLE SPINAL S/SU 22GA 3-1/2 IN QUINCKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "STYLET WAS LONGER THAN THE NEEDLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781044 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SPINAL FLUID LEAKED DUE TO CRACK AT THE NEEDLE HUB WITH BD NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405181 BATCH NO: 8218535. IT WAS REPORTED THAT SPINAL FLUID LEAKED FROM A SMALL CRACK IN THE NEEDLE. ISSUE WE HAD REGARDING THE SPINAL NEEDLE # 405181. WHEN IT WAS BEING USED WITH A PATIENT, SPINAL FLUID BEGAN LEAKING OUT FROM A SMALL CRACK¿ THE DEPARTMENT REMOVED THE NEEDLE STRAIGHT FROM THE BOX THAT IT HAD BEEN SHIPPED IN WITH THE PACKAGING SECURELY AROUND IT. ADDITIONAL CUSTOMER'S RESPONSE TO INFO REQUEST STATES: ¿ PLEASE CONFIRM WHERE THE CRACK WAS LOCATED (I.E. SIDE OF THE NEEDLE, NEEDLE HUB, ETC.).- CRACK WAS LOCATED AT THE NEEDLE HUB; ¿ WAS ANY MEDICAL INTERVENTION OR OTHER ACTIONS TAKEN AS A RESULT? NO; ¿ ARE YOU ABLE TO PROVIDE ANY PATIENT IDENTIFIERS (I.E. INITIALS, GENDER, WEIGHT, ETC.)? AVERAGE SIZE PATIENT, FEMALE; ¿ WAS ANY STAFF EXPOSED TO THE SPINAL FLUID? NO; ¿ IS THE AFFECTED SAMPLE STILL AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8705414 ↗
• InjuryDec 21, 2017Product Quality Problem

  IT WAS REPORTED THAT A PATIENT CONTRACTED A FUNGAL INFECTION AFTER RECEIVING AN EPIDURAL INJECTION USING A BD¿ QUINCKE SPINAL NEEDLE, BLACK HUB. THE PATIENT HAD AN EPIDURAL INJECTION ON (B)(6) 2017 AND WENT TO THE EMERGENCY ROOM (ER) WITH LOW BACK PAIN ON (B)(6) 2017. AN MRI CONFIRMED AN EPIDURAL ABSCESS. THE PATIENT HAD SURGERY TO REMOVE AND CULTURE THE ABSCESS AND UNDERWENT REHAB. THE PATIENT IS REPORTEDLY DOING WELL AT THIS TIME.

  Patient problems: Abscess; Fungal Infection; Pain

  MAUDE report 7137159 ↗
• MalfunctionDec 13, 2017Appropriate Device Problem Term/Code Not Available

  STYLET EXTENDS PAST THE TIP OF THE NEEDLE.

  Patient problems: No Information

  MAUDE report 7112155 ↗