BD Cathena™ Safety IV Catheter 386881Recalls & reported problems
Becton, Dickinson And Company · US CATHENA 22GX1.00IN WINGED BC · Class 2
All models of BD Cathena Safety IV Catheter (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903868810), received between Apr 16, 2021 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (3 reports).
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
Most reported problems
Device problems
- Activation Problem3
- Activation, Positioning or Separation Problem1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948300 ↗MalfunctionMay 12, 2026Activation Problem
IT WAS REPORTED BY CUSTOMER THAT ""CATHENA SAFETY MECHANISM DID NOT ENGAGE. LEAVING THE NEEDLE EXPOSED"" VERBATIM: CATHENA SAFETY MECHANISM DID NOT ENGAGE. LEAVING THE NEEDLE EXPOSED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150370 ↗MalfunctionApr 30, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT WE HAD ANOTHER CATHENA NOT SAFETY, VERBATIM: WE HAD ANOTHER CATHENA NOT SAFETY, THIS ONE WAS A WINGED VERSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045756 ↗MalfunctionApr 28, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE APPEARED BENT BEFORE ENTERING PATIENT. WHEN THE CATHETER WAS PULLED FROM THE NEEDLE, THE NEEDLE PROTECTOR DID NOT EXTEND, SO FULL NEEDLE WAS EXPOSED. SAFETY DEVICE WAS PULLED DOWN SEPARATELY, NEEDLE COVERED APPROPRIATELY AND DEVICE DISCARDED. CATHETER PULLED FROM PACKAGE TO USE ON PATIENT. WRITER NOTICED THE DEVICE APPEARED BENT BEFORE ENTERING PATIENT. WHEN THE CATHETER WAS PULLED FROM THE NEEDLE, THE NEEDLE PROTECTOR DID NOT EXTEND, SO FULL NEEDLE WAS EXPOSED. SAFETY DEVICE WAS PULLED DOWN SEPARATELY, NEEDLE COVERED APPROPRIATELY AND DEVICE DISCARDED."
Patient problems: Needle Stick/Puncture
MAUDE report 25017375 ↗MalfunctionApr 16, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT US CATHENA 22GX1.00IN WINGED BC HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 386881 BATCH NO.: UNKNOWN IT WAS REPORTED THAT THE 22G 1" CATHENA CATHETER SAFETY DID NOT ENGAGE WHEN OFF OF CATHETER. VERBATIM: CUSTOMER UNSURE IF SHE FORCED THE WHITE PART OFF OF CATHETER HUB PRIOR TO SAFETY OR IF IT FREELY CAME OFF. SHE WAS ABLE TO SAFETY AFTER DETACHED FROM CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11682137 ↗
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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
- 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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