N/A 305187Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903051878), received between Oct 4, 2019 and Jan 28, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD¿ NEEDLE 1 1/2 IN. THIN WALL, SINGLE USE, STERILE, 19 G HAD EPOXY ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I AM WRITING TO INFORM YOU THAT WE HAVE NOTICED UNEXPECTED WHITE SPECKS ON THE NEEDLES USED FOR STERILE COMPOUNDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385797 ↗
• MalfunctionNov 8, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLES CAME WITH A MIX OF PRODUCT TYPES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305187, BATCH NO.: 9030182. IT WAS REPORTED THAT TWO DIFFERENT NEEDLES WERE RECEIVED IN THE SAME LINE OF PRODUCT WITH SERRATED TEAR LINES. REPORTER STATED THAT 2 NEEDLES WERE FOUND IN SAME PACKAGE. SHE SAID THAT SHE CAN EMAIL US WITH PHOTOS AND MORE DETAILS. REPORTER SAID THAT IT WAS NOTICED "LATE YESTERDAY" (10/23/19). PER RELATED EMAIL: NEEDLES PACKAGED IN THE SAME LINE OF PRODUCT WITH SERRATED TEAR LINES. ONE HAS A BLACK HUB COLOR AND IS SHORTER WITH A SMALLER GAUGE NEEDLE. THE OTHER HAD A BROWN HUB AND IS LONGER WITH A LARGER GAUGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295706 ↗
• MalfunctionOct 31, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX HAS A MIX OF PRODUCT WITH DIFFERENT COLORED HUBS WITH A BD NEEDLE 19X1-1/2 RB. THIS OCCURRED ON 2 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BOXES CONTAINED OTHER SIZE NEEDLES WITH DIFFERENT COLORED HUBS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9261977 ↗
• MalfunctionOct 22, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT MIXED PRODUCT WAS FOUND BEFORE USE WITH A NEEDLE 19X1-1/2 RB TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS INFORMED TO ME THAT SHE MET WITH THE STOREROOM MANAGER AND THEY HAVE 10 BOXES, ALL THE SAME LOT NUMBER IN WHICH A SHORTER NEEDLE WAS PACKAGED AS A 19G X 1 1/2 NEEDLE. THE SHORTER NEEDLE HAS A GRAY COLOR HUB VS. BROWN COLOR HUB OF THE ACTUAL 19G X 1 1/2". " 10 OCCURRENCES WERE FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220538 ↗
• MalfunctionOct 7, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT MIXED PRODUCT OCCURRED WITH A NEEDLE 19X1-1/2 RB TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAVE A MAJOR ISSUE WITH SOME BD NEEDLES ¿ SIZE 19G X 1 ½ REF 305187. AN ENTIRE PACK OF NEEDLES THAT WERE TWO DIFFERENT SIZES IN THE PACK. SAME LOT NUMBER: 9030812."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9163849 ↗
• MalfunctionOct 4, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL NO: 305187 BATCH NO: 9030812, 8250805 & 8292593. IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 19X1-1/2 RB TW THE PACKAGE WAS MIXED WITH NEEDLES OF DIFFERENT SIZES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES ARE ODD SIZES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9156422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications