BD Cathena Safety IV Catheter 386809Recalls & reported problems
Becton, Dickinson And Company · CATHENA 18GX2.00IN 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903868094), received between Jul 2, 2024 and Jan 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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
- Device Markings/Labelling Problem1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21125708 ↗MalfunctionJul 2, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
THE NEEDLE SAFETY GUARD DID NOT ACTIVATE. THAT IS, AFTER THE INJECTION, THE TIP OF THE NEEDLE WAS EXPOSED AND THE PROTECTION REMAINED ATTACHED TO THE BODY OF THE NEEDLE, I.E. IN ITS ORIGINAL POSITION. IT ALSO SEEMS THAT THE NEEDLE WAS NOT COMPLETELY IN THE BLADE, AS IT FELT LIKE THE PATIENT HAD SUCH IMPOSSIBLY THICK SKIN, WHEN THE NEEDLE DID NOT WANT TO GO THROUGH THE SKIN. HOWEVER, CANNULATION SUCCEEDED AND THE CANNULA ITSELF WORKED. DURING USE. THE NEEDLE SAFETY GUARD DID NOT ACTIVATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657555 ↗
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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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