BD Cathena Safety IV Catheter 386821Recalls & reported problems
Becton, Dickinson And Company · CATHENA 24GX0.75IN WINGED · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903868216), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS WAS DAMAGED AND DETACHED FROM THE NEEDLE TOO EASILY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING THE FIRST ATTEMPT TO INSERT A CATHLON (24G), IT IS IMPOSSIBLE TO GUIDE THE CATHLON BECAUSE IT DISSOCIATES TOO EASILY FROM THE NEEDLE, FORCED TO KEEP THE CATHLON PROXIMAL, THEREFORE LACK OF ASEPSIS. MOREOVER, THE CATHLON IS TOO FLEXIBLE AND THEREFORE CANNOT BE HELD IN THE VEIN. AT THE SECOND ATTEMPT, BLOOD RETURN WAS PRESENT BUT AFTER FIXATION THE DIFFUSE VENOUS ROUTE WAS PRESENT. IN THE THIRD ATTEMPT, WITH A 22G CATHLON, THE NEEDLE AND THE CATHLON DISSOCIATED AS SOON AS IT WAS INTRODUCED SUBCUTANEOUSLY AND COULD NOT BE GUIDED: THE INSERTION FAILED. CONCLUSION: 3 UNSUCCESSFUL INSERTION ATTEMPTS DUE TO DEFECTIVE OR POOR QUALITY MATERIAL. THE VENOUS ROUTE WAS FROM THE FIRST ATTEMPT WITH ANOTHER TYPE OF CATHLON." "CLINICAL CONSEQUENCES: CHILD ON MEOPA FOR A LONG PERIOD OF TIME WHICH ENDED IN VOMITING."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10709338 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
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- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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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