BD Nexiva™ Closed IV Catheter System 383641Recalls & reported problems
Becton, Dickinson And Company · BD Nexiva™ Closed IV Catheter System 24GA x 0.75IN · Class 2
All models of BD Nexiva Closed IV Catheter System (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903836413), received between Dec 5, 2024 and May 6, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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/Splash4
- Fluid/Blood Leak2
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Fluid/Blood Leak
DURING USE, THE END CAP DOES NOT SEAL PROPERLY WITH THE CANNULA BODY, CAUSING BLOOD TO LEAK. THERE ARE 10 DEFECTIVE UNITS. TWO DEFECTIVE PRODUCTS CAN BE RETURNED, AND PHOTOGRAPHS ARE AVAILABLE. WE REQUIRE A CLAIM SETTLEMENT, A RESPONSE TO THE COMPLAINT, AND A RECEIPT OF THE COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104162 ↗MalfunctionApr 16, 2026Fluid/Blood Leak
DURING USE OF THIS PRODUCT, IT WAS DISCOVERED THAT THE PINCH CLAMP WAS DAMAGED AND FAILED TO SECURE THE TUBING PROPERLY, RESULTING IN BLOOD LEAKAGE; TWO UNITS WERE AFFECTED; PHYSICAL DEVICES CANNOT BE RETURNED, BUT PHOTOGRAPHS ARE AVAILABLE; A GREEN CLAIM IS REQUIRED, ALONG WITH A RESPONSE LETTER TO THE COMPLAINT AND A COMPLAINT ACKNOWLEDGMENT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24898994 ↗MalfunctionFeb 17, 2026Leak/Splash
DURING USE, LEAKAGE OCCURRED AT THE CATHETER CONNECTION POINT. TWO DEFECTIVE UNITS WERE IDENTIFIED. ONE DEFECTIVE UNIT MAY BE RETURNED, WITH PHOTOGRAPHIC EVIDENCE PROVIDED. A CLAIM IS REQUIRED, ALONG WITH A COMPLAINT RESPONSE LETTER AND A COMPLAINT RECEIPT CONFIRMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366908 ↗MalfunctionSep 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y W/ CAP. LEAKAGE. WE HAVE RECEIVED A COMPLAINT FROM OUR DEPARTMENT REGARDING THIS PRODUCT, SPECIFICALLY LOT NUMBER 5085401. DURING USE, IT WAS OBSERVED THAT THE PRODUCT LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036890 ↗MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y W/ CAP LEAKED, THE NEXIVA PRODUCT IS LEAKING WATER AT THE QSITE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716990 ↗MalfunctionDec 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA W/ CAP LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: LEAKAGE AT SPLIT NEEDLE HOSE. 27 NOV WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? YES. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO. WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? YES. IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED. NACL 0.9%. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20874769 ↗MalfunctionDec 5, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858777 ↗
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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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