BD Cathena Safety IV Catheter 386810Recalls & reported problems
Becton, Dickinson And Company · CATHENA 20GX1.00IN 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903868100), received between Apr 13, 2021 and May 6, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Retraction Problem2
- Activation Problem1
- Break1
- Contamination1
- Material Perforation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Needle Stick/Puncture2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
IT WAS REPORTED THAT BD CATHENA 20GX1.00IN WINGED BC NEEDLE SHIELDING FAILED. DATE OF OCCURRENCE: (B)(6) 2025. REFERENCE: 386810. BATCH NUMBER: 4180596. DESCRIPTION OF DEFECT: DURING THE INSERTION OF A PERIPHERAL VENOUS LINE WITH THE SECURE WINGED CATHETER, A NURSE PRICKED HERSELF DUE TO A SECURING RELEASE FAULT. IN ADDITION, THE PATIENT HAD SEPSIS CAUSED BY HIGHLY RESISTANT BACTERIA. THE NURSE WAS TREATED AS AN EMERGENCY ACCORDING TO THE BLOOD EXPOSURE ACCIDENT (BEA) PROTOCOL. THE DEFECTIVE MEDICAL DEVICE WAS RETAINED. WOULD YOU LIKE THE CASE TO BE RETURNED FOR EXPERT APPRAISAL?
Patient problems: Needle Stick/Puncture
MAUDE report 21969394 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY LEAKED AT THE BASE DURING THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LEAK AT THE BASE OF THE CATHETER DURING INSERTION, AFTER SUCCESSFUL PUNCTURE OF THE VEIN AND CONNECTION TO THE VEIN GUARD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620070 ↗InjuryMar 7, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD CATHENA¿ IV CATHETER SAFETY MECHANISM WILL NOT ACTIVATE AND CAUSE A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSERTION OF THE 20G CATHETER, THE SAFETY DEVICE DID NOT WORK. THE NURSE THEREFORE PRICKED HERSELF.
Patient problems: Needle Stick/Puncture
MAUDE report 16496448 ↗MalfunctionDec 23, 2022Contamination; Contamination
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN ABOUT TO INSERT IV IN PT'S ARM AND NOTICED A SMALL PIECE OF PLASTIC AT THE TIP OF THE CANNULA. IV WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16043366 ↗MalfunctionDec 20, 2021Material Perforation; Material Perforation
IT WAS REPORTED THAT AFTER REMOVING THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY FROM THE PACKAGING AND MOVING IT AROUND, THE NURSE FOUND THAT THE NEEDLE HAD PIERCED THROUGH THE TIP OF THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN WAS ABOUT TO START AN IV ON A PATIENT. WHEN THE RN OPENED THE PACKAGING, THE RN SLID THE CATHETER BACK AND FORTH, AND NOTICED A PIECE OF PLASTIC AT THE TIP OF THE CANNULA."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13048338 ↗MalfunctionDec 8, 2021Break; Break
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV BLOOD COLLECTION WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED DEFECTIVE CATHETER .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12964970 ↗MalfunctionApr 13, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE ON THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY FAILED TO WORK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE MECHANISM THAT ENSURES THE NON-RETURN OF BLOOD DID NOT WORK DURING THE INSTALLATION OF A KT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11657181 ↗
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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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