BD Cathena Safety IV Catheter 386818Recalls & reported problems
Becton, Dickinson And Company · CATHENA 24GX0.75IN STRAIGHT · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903868186), received between Aug 14, 2019 and Sep 16, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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.
Most reported problems
Device problems
- Material Protrusion/Extrusion2
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER SAFETY MECHANISM WOULD NOT ACTIVATE AND BECAME DISENGAGED WHEN ATTEMPTING TO RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "AFTER INSERTING THE CATHETER INTO THE PATIENT'S VEIN, THE SAFETY SYSTEM THAT WAS SUPPOSED TO RECOVER THE NEEDLE BECAME DISENGAGED. THE NEEDLE COULD NOT RETRACT INTO THE SYSTEM. PROVEN CONSEQUENCES: ABSENCE. POTENTIAL CONSEQUENCES: RISK OF BLOOD EXPOSURE ACCIDENT. RISK OF PATIENT INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12485009 ↗MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN USING THE BD CATHETER 24GX0.75IN STRAIGHT, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AN EXTENSION TUBE WAS FITTED TO THE CATHETER TO ALLOW AN INJECTION TO BE MADE IF NECESSARY. THE OPERATOR CHECKED THAT THE EXTENSION WAS SECURE AS SHE HAD PREVIOUS EXPERIENCE OF LEAKAGE. WHEN INJECTING ANTIBIOTICS, THE SYRINGE PUMP SOUNDS THE OCCLUSION. CHECK OF THE CATHETER: LEAKAGE AROUND THE EXTENSION TUBE WHICH HAD UNSCREWED AND THE CATHETER WAS OBSTRUCTED. (EVENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12442334 ↗MalfunctionAug 19, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT SAFETY MECHANISM WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM WITH THIS CATHETER IS THAT THE WHITE PART THAT NORMALLY SECURES THE MANDREL DID NOT FIT. IT REMAINED IN THE TRANSPARENT PART OF THE CATHENA AND THEREFORE DID NOT SECURE THE MANDREL. THE NURSE DID NOT MENTION ANY PARTICULAR MANIPULATION THAT COULD HAVE CAUSED THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342784 ↗MalfunctionAug 14, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 100 CATHENA 24GX0.75IN STRAIGHT EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB IS MISSING THE BLOOD CONTROL MECHANISM RESULTING IN BLOOD SPILL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8894830 ↗
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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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