BD QUINCKE Spinal Needles 408360Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382904083601), received between Jul 16, 2019 and Feb 12, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionFeb 12, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322466 ↗
• MalfunctionAug 23, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD¿ LONG LENGTH SPINAL NEEDLE EXPERIENCED INCONSISTENT LABELLING INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFERING EXPIRY DATE STATED ON THE CERTIFICATE OF COMPLIANCE AND THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277750 ↗
• MalfunctionMar 9, 2020Break; Break

  IT WAS REPORTED THAT DURING QUALITY CONTROL TESTING A NEEDLE SPINAL S/SU 18GA 6 IN QUINCKE WAS FOUND TO NOT ALLOW REINSERTION OF THE STYLET INTO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HERE IS A PHOTOGRAPH OF THE BD PACKAGES AND THE LOT NUMBER OF THE NEEDLE THAT FAILED QC. THEY RECEIVED 2 LOTS AND THE FIRST LOT OF 50 NEEDLES WAS USED AND PASSED OUR INSPECTION TEST. FOR THE SECOND LOT, THERE WERE 20 UNITS RECEIVED IN TWO BOXES. WE OPENED ONE AND DID THE INSPECTION. THE STYLET WOULDN'T REINSERT INTO THE NEEDLE. SO THERE ARE 19 UNOPENED NEEDLES AND THE ONE THAT WAS USED TO INSPECT. AS YOU CAN SEE, THE RANDOMLY SELECTED NEEDLE FROM THAT LOT WOULD NOT ALLOW REINSERTION INTO THE NEEDLE. WE REJECT THE ENTIRE LOT BASED ON THIS RESULT"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9804542 ↗
• InjuryFeb 4, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SPINAL S/SU 18GA 6IN QUINCKE EXPERIENCED PRODUCT DAMAGE/DEFORMATION -DEVICE STILL OPERABLE, AND WERE INVOLVED IN A SERIOUS INJURY IN THE FORM OF MEDICAL INTERVENTION. DURING TREATMENT, A PORTION OF THE DEVICE BECAME EMBEDDED WITHIN THE PATIENT'S KIDNEY AND HAD TO BE REMOVED BY A HEALTH CARE PROFESSIONAL. NO ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THIS MEDICAL INTERVENTION HAS BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEVICE IN QUESTION IS: AIG PL 150MM 18G 408360, REF: 408360 AND NUMBER OF SERIES: 8123805 AND 9088609. THE PROBLEM ENCOUNTERED IS: "DURING AN NLPC (NEPHROLITHOTOMY PER CUTANEOUS) USE OF THE SPINAL NEEDLE TO LOCATE THE KIDNEY. SMALLER NEEDLE DIAMETER AT THE END OF THE NEEDLE IMPEDING THE PASSAGE OF THE GUIDE THAT "SPINS" AND CAN'T REMOVE THE GUIDE." CLINICAL CONSEQUENCES: "RUPTURE OF PART OF THE GUIDE WIRE IN THE PATIENT'S KIDNEY. THIS PART HAD TO BE RECOVERED."

  Patient problems: Injury

  MAUDE report 9667274 ↗
• MalfunctionJul 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SPINAL S/SU 18GA 6 IN QUINCKE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 SPINAL NEEDLE MISSING IN 1 BOX (PRESENCE OF 9 NEEDLES INSTEAD OF 10). 1 SPINAL NEEDLE WITH AN IMPURITY OR INK STAIN INSIDE THE BLISTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795142 ↗