N/A 304142Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903041428), received between Jun 7, 2025 and Apr 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Perforation

  IT WAS REPORTED NEEDLE PIERCED THROUGH THE SHEATH. ADDITIONAL INFORMATION: "BLOOD WAS DRAWN FROM THE PATIENT, AREA WAS CLEANED WITH BETADINE THOROUGHLY, MANAGEMENT NOTIFIED." FACILITY REPORTS NO MEDICAL INTERVENTION OR FOLLOW-UP CARE WAS NEEDED, INDIVIDUAL IS DOING "FINE." NO ADDITIONAL INFORMATION AT THIS TIME. NO MEDICAL INTERVENTION, SERIOUS INJURY, OR FOLLOW-UP CARE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910370 ↗
• MalfunctionJan 5, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD NEEDLE 23GA 1-1/2IN BNS TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304142 BATCH # 5050183. IT WAS REPORTED BY CUSTOMER THAT A COMPLAINT SAMPLE FOR CARDINAL HEALTH COMPLAINT NUMBER CASE- (B)(4). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED A COMPLAINT SAMPLE FOR XXXXXX COMPLAINT NUMBER CASE- (B)(4). PLEASE SEE THE ATTACHED PHOTOS OF THE AFFECTED SAMPLE. IF YOU REQUIRE THE SAMPLE TO BE RETURNED FOR INVESTIGATION, PLEASE PROVIDE A SHIPPING LABEL. THANK YOU, ADDITIONAL INFORMATION: MATERIAL NUMBER: 304142. LOT NUMBER: 5050183. PATIENT IMPACT: NO. SAMPLE AVAILABLE: YES. NEEDLE FROM BACK TABLE PACK HAD WHITE SUBSTANCE ON IT BEFORE EVER BEING UNCAPPED. NEEDLE DEFECTIVE IN PACK FROM MANUFACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969364 ↗
• MalfunctionJun 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THE DEBRIS FOUND INSIDE THE NEEDLE CASING. VERBATIM: DEBRIS FOUND INSIDE THE NEEDLE CASING SUPPLIER PRODUCT #: 304142 LOT #: 4331011 CUSTOMER RESPONSE ON 03-JUN-2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 5/28/2025..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162616 ↗

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