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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 · 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

Other Needle, hypodermic, single lumen devices

All Needle, hypodermic, single lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.