BD Cathena™ Safety IV Catheter 386862Recalls & reported problems
Becton, Dickinson And Company · US CATHENA 20GX1.00IN STRAIGHT BC · Class 2
All models of BD Cathena Safety IV Catheter (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Cathena safety IV catheter is a short-term catheter placed into a vein. Its 183 reports include no deaths and 2 injuries, and in the last 12 months there were 17, down from 118. Many describe blood leaking from the catheter and safety shields that fail to activate. There is 1 open recall, started in August 2023, over safety shields that may let the needle pull free and leave it exposed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 206
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 00382903868629), received between Dec 2, 2021 and Sep 29, 2026 — classified as 2 injuries, 204 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (62 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 29, 2023Class IIOpen, Classified
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
Z-0025-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak62
- Activation Problem46
- Leak/Splash38
- Retraction Problem19
- Material Separation11
- Defective Component8
- Material Protrusion/Extrusion6
- Activation Failure5
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- Insufficient Information6
- Needle Stick/Puncture4
- Fluid Discharge3
- Anxiety1
- Awareness During Anesthesia1
- Discomfort1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935049 ↗MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935047 ↗MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935046 ↗MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935044 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903522 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902822 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902821 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902820 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902819 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902817 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902816 ↗MalfunctionSep 25, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902812 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892040 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891449 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891446 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890872 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890871 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890869 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890868 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890866 ↗MalfunctionSep 24, 2026Activation Problem
It was reported by the customer that had two more incidents where the safety mechanism of these IVs did not engage, thus exposing bare needle after removal. Verbatim: I wanted to make you aware that we had two more incidents where the safety mechanism of these IVs did not engage, thus exposing bare needle after removal. Morning shift ASU (xxxx inserted) 20 GA 1.00IN REF# 386862, LOT# 6037534. (I have the IV needle in my office and packaging). Afternoon shift ASU (xxxx RN inserted) 20 GA 1.00IN REF #386862, LOT # 6042821, (IV needle discarded and I do not have packaging). No patient or team member incidents reported related to exposed needle.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884806 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884803 ↗MalfunctionSep 15, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776520 ↗MalfunctionSep 15, 2026Activation Problem
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776486 ↗MalfunctionSep 15, 2026Activation Problem
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776483 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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