BD Cathena Safety IV Catheter 386812Recalls & reported problems
Becton, Dickinson And Company · CATHENA 20GX2.00IN 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903868124), received between Sep 23, 2020 and Jul 15, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash3
- Retraction Problem2
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Material Protrusion/Extrusion1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2024Retraction Problem; Material Protrusion/Extrusion; Retraction Problem; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD CATHENA 20GX2.00IN WINGED BC SAFETY SHIELD ACTIVATION FAILED (CATHETER). I WOULD LIKE TO LEAVE YOU A COMPLAINT ABOUT CATHENA (ATTACHMENT). THE SAFETY MECHANISM DID NOT ACTIVATE AND GOT STUCK AT THE BASE OF THE NEEDLE. THEREFORE, THE NEEDLE WAS HAZARDOUS. THIS HAS HAPPENED BEFORE AS WELL (PREVIOUS COMPLAINT NUMBER (B)(4) ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19744729 ↗MalfunctionAug 9, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED THAT WHILE USING THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY THE SAFETY REMOVAL WAS BLOCKED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION. SAFETY REMOVAL BLOCKED.
Patient problems: Insufficient Information
MAUDE report 17495054 ↗InjuryDec 15, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED WHILE USING BD CATHENA¿ SAFETY IV CATHETER WITH WINGS DISCONNECTION OCCURRED AND LED TO LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MALFUNCTION OF THE CONNECTION IN THE OPERATING ROOM, CAUSING ADVERSE EVENTS IN THE PATIENT. THE ANESTHESIA SERVICE REPORTS THAT ON SEVERAL OCCASIONS THE INFUSION SYSTEM WAS DISCONNECTED FROM THE CATHETER, CAUSING DRUG LEAKS AND IMPACTING THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15992840 ↗MalfunctionOct 29, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY WAS DEFECTIVE AND DISCONNECTED FROM THE LUER-LOCK OF THE INFUSION SET DURING USE, CAUSING FLUID TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "DISCONNECTION AND FLUID LEAKAGE AT THE JUNCTION OF THE CATHETER HUB WITH THE LUER LOCK CONNECTION OF THE INFUSION SET. DISCONNECTION AND FLUID LEAKAGE AT THE JUNCTION OF THE CATHETER HUB WITH THE LUER LOCK CONNECTION OF THE INFUSION SET OR EXTENSION SET. DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695691 ↗MalfunctionSep 23, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA SAFETY IV CATHETERS WITH WINGS BD MULTIGUARD TECHNOLOGY 20 GA 2.00 IN EXPERIENCED CATHETER DAMAGE/DEFORMATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKING OF THE PLASTIC PORTION OF THE CANNULA. DAMAGE IS ON THE CUTTING EDGE OF THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10577949 ↗
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- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
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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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