N/A 305129Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 21X2 RB · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903051298), received between Feb 14, 2019 and Jun 7, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material3
- Break1
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Incomplete or Missing Packaging1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Break; Break
MATERIAL #: 305129 BATCH#: 3145333 IT WAS REPORTED BY CUSTOMER THAT THE DISCOVERED THE BROKEN NEEDLE CONNECTOR WHEN THE PRODUCT WAS OPENED. NO INJURY REPORTED. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. THE DISCOVERED THE BROKEN NEEDLE CONNECTOR WHEN THE PRODUCT WAS OPENED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484159 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE UNSPECIFIED BD BLOOD VACUTAINER COLLECTION SET, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CONSUMER THE TUBE WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432004 ↗MalfunctionMar 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G HAD THE NEEDLE PULL OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE CAME OUT OF HUB WHILE IN USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13897293 ↗MalfunctionJul 7, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT NEEDLE 21X2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THERE IS A WHITE GLUE-LIKE SUBSTANCE ON THE NEEDLE AND THE SAFETY COVER IS DIFFICULT TO GET OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132257 ↗MalfunctionSep 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A "BUG" WAS OBSERVED STUCK TO THE NEEDLE 21X2 RB BEFORE USE AFTER IT HAD BEEN OPENED FROM ITS PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, ONE OF THE NURSE¿S OPENED A STERILE BD PRECISION GLIDE NEEDLE AND WHAT APPEARS TO BE A BUG STUCK TO THE NEEDLE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8966303 ↗MalfunctionMay 6, 2019Device Markings/Labelling Problem
IT WAS REPORTED THAT LABEL IS MISSING WITH A BD¿ NEEDLE 21X2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE MASTER CARTON LABEL IS MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8584460 ↗MalfunctionFeb 21, 2019Incomplete or Missing Packaging
BECTON, DICKINSON AND COMPANY, BD PRECISION GLIDE NEEDLE, 21G X 2 (0.8MM X 50MM) INJECTION NEEDLE NOT INCLUDED IN SEALED, STERILE PACKAGING. ONLY THE CAP WAS IN THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8362957 ↗MalfunctionFeb 14, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A BD¿ PRECISIONGLIDE¿ HAD A NEEDLE TIP THAT WAS COVERED IN WHITE MATERIAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8341884 ↗
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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.