BD Cathena™ Safety IV Catheter 386883Recalls & reported problems
Becton, Dickinson And Company · US 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903868834), received between Sep 24, 2024 and Aug 22, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole2
- Contamination1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN WINGED BC - NEEDLE THROUGH CATHETER. IT WAS REPORTED BY THE CUSTOMER THAT WHEN RETRACTING THE NEEDLE IT IS PIERCING THROUGH THE CATHETER. THIS SHOULD BE ABLE TO BE INSERTED AND RETRACTED WITHOUT THE NEEDLE CAUSING DAMAGE TO THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874171 ↗MalfunctionAug 18, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN WINGED BC NEEDLE THROUGH CATHETER IT WAS REPORTED BY CUSTOMER THAT WHEN RETRACTING THE NEEDLE IT IS PIERCING THROUGH THE CATHETER. THIS SHOULD BE ABLE TO BE INSERTED AND RETRACTED WITHOUT THE NEEDLE CAUSING DAMAGE TO THE CATHETER. RCC RECEIVED A COMPLAINT VIA EMAIL. 20 GAUGE. LOT # 4005488 - 2 BOXES OF 30, 60 TOTAL, 9 USED, 51 LEFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828097 ↗MalfunctionApr 28, 2025Contamination; Contamination
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN WINGED BC HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THERE APPEARS TO BE TINY PLASTIC STUCK IN THE TIP OF THE NEEDLE AND THE NEEDLE TIP APPEARS BENT AS WELL. VERBATIM: THERE APPEARS TO BE TINY PLASTIC STUCK IN THE TIP OF THE NEEDLE AND THE NEEDLE TIP APPEARS BENT AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21918148 ↗MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN WINGED BC CATHETER WAS DEFECTIVE AND LEAKED IT WAS REPORTED BY CUSTOMER THAT TWO CATHETERS SO FAR ARE DEFECTIVE. BOTH TIMES BLOOD HAS SQUIRTED OUT OF THE CANNULA THAT IS SUPPOSED TO BE IN THE VEIN. THEY THINK THERE IS A HOLE BETWEEN THE CANNULA AND BODY OF THE CATHETER. THESE HAVE ZERO BLOOD STOPPING TECHNOLOGY IN ADDITION TO THESE SO THE BIBS THEY USE ARE SATURATED IN BLOOD. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO ITEM: 386883 QUANTITY AFFECTED: 2 BX SERIAL/LOT NUMBER: (B)(6) PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: THIS STUDIO IS REPORTING TWO CATHETERS SO FAR ARE DEFECTIVE. BOTH TIMES BLOOD HAS SQUIRTED OUT OF THE CANNULA THAT IS SUPPOSED TO BE IN THE VEIN. THEY THINK THERE IS A HOLE BETWEEN THE CANNULA AND BODY OF THE CATHETER. THESE HAVE ZERO BLOOD STOPPING TECHNOLOGY IN ADDITION TO THESE SO, THE BIBS THEY USE ARE SATURATED IN BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753401 ↗MalfunctionMar 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN WINGED BC HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT SAFETY DID NOT DEPLOY CORRECTLY. VERBATIM: SAFETY DID NOT DEPLOY CORRECTLY. CUSTOMER RESPONSE RECEIVED ON (B)(6)2025. WE DID NOT HAVE ANY NEGATIVE OUTCOME HOWEVER THE POTENTIAL FOR ONE OF THE NURSES TO GET A NEEDLE STICK BECAUSE THE NEEDLE DID NOT RETRACT IS STILL SIGNIFICANT. THIS OCCURRED MULTIPLE TIMES WITH THE 22G AND 20G. I SENT (B)(6) THE PICTURE LAST WEEK. CUSTOMER RESPONSE RECEIVED ON (B)(6)2025. 1. PLEASE SHARE THE MATERIAL & LOT NUMBER ASSOCIATED WITH 20G 4178006. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT FOR 20G? 3. IF POSSIBLE, CAN YOU PLEASE PROVIDE THE TOTAL NUMBER OF OCCURRENCES FOR BOTH 22G AND 22G. 4. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE FOR 20G AND 22G CATHENA? IF SO, KINDLY SEND THE SAMPLES USING THE NEW SHIPPING LABEL. THE ISSUE IS THAT YOU DON'T KNOW THAT THERE IS A PIECE OF PLASTIC ON THE NEEDLE UNTIL YOU OPEN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654415 ↗MalfunctionSep 24, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
MATERIAL # 386883 BATCH # 4068002 IT WAS REPORTED BY CUSTOMER THAT THE CATHENA SAFETY NOT ENGAGING. VERBATIM: CATHENA SAFETY NOT ENGAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292863 ↗
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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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