N/A 305143Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 23X3/4 RB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903051434), received between Oct 13, 2023 and Oct 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2023Crack; Crack
IT WAS REPORTED THAT THE BD¿ NEEDLE 3/4 IN. SINGLE USE, STERILE HUB WAS CRACKED AND LEAKING OCCURRED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WE HAVE EXPERIENCED LEAKS FROM THE NEEDLE HUB OF 2 SUPPLIES: 22GA. INSYTE AUTOGUARD AND 23GA. PRECISIONGLIDE NEEDLE. I DON¿T HAVE LOT NUMBER INFORMATION FROM EACH AS THEY WERE IN USE AND UNABLE TO TRACK BACK TO THE ORIGINAL PACKAGING. IT APPEARS TO BE LEAKING AT A SPOT THAT IS FOUND ON ALL BD PRODUCTS (VARIOUS SIZE NEEDLES AND INSYTE AUTOGUARD). IT MAY BE THAT THIS SPOT/DEFECT PENETRATES ALL THE WAY THROUGH THE SIDE OF NEEDLE HUB AS SEEN IN THE ATTACHED PHOTO. HAS THIS BEEN REPORTED OR IS THERE AWARENESS OF THIS ISSUE? ARE THERE ANY PRODUCTS RECALLS TO BE AWARE OF? IN THE FIELD OF NUCLEAR MEDICINE TECHNOLOGY, THIS IS PROBLEMATIC AS WE INJECT RADIOPHARMACEUTICALS THROUGH THESE SUPPLIES. WHEN THEY LEAK, IT CREATES CONTAMINATION TO THE PATIENT SKIN, EQUIPMENT AND FLOOR AND THE INTENDED ROUTE OF ADMINISTRATION IS NOT BEING DELIVERED TO THE PATIENT AS REQUIRED FOR IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17935232 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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