BD Nexiva™ Closed IV Catheter System 383647Recalls & reported problems
Becton, Dickinson And Company · BD Nexiva™ Closed IV Catheter System 20GA x 1.25IN · 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903836475), received between Apr 8, 2024 and May 15, 2026 — classified as 8 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
- Material Deformation1
- Material Integrity Problem1
- Material Rupture1
- Material Separation1
- Material Split, Cut or Torn1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Extravasation1
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE TUBING BROKE. 20G NEXIVA DUAL PORT INSERTED THE MORNING OF THE 29TH OF APRIL, PATIENT HAD A SHOWER AND HAD A PLASTIC SHOWER SLEEVE INSITU. WHEN SHOWER SLEEVE REMOVED, BLOOD NOTICED, NEXIVA EXTENSION SET WAS IN 2 PIECES, SLICED DIRECTLY ACROSS. UNKNOWN AS TO HOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25188571 ↗MalfunctionDec 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20GA 1.25IN HF Y W/ CAP LEAKAGE AT CATHETER JUNCTION WHEN IN USE, THE EXTENSION TUBING LEAKED AT THE CONNECTION TO THE CATHETER ADAPTER, DEFECTIVE QUANTITY 1, UNABLE TO RETURN DEFECTIVE PRODUCT, NO PHOTOS PROVIDED. CLAIMS NEED TO BE SETTLED, COMPLAINT RESPONSE LETTER NEEDED, COMPLAINT RECEIPT LETTER NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935474 ↗MalfunctionAug 20, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848918 ↗MalfunctionAug 1, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690117 ↗MalfunctionDec 13, 2024Leak/Splash; Separation Failure; Leak/Splash; Separation Failure
IT WAS REPORTED THAT LEAKAGE AT SEPTUM AND DIFFICULTY WITHDRAWING NEEDLE CORE OCCURRED. ON (B)(6) 2025 CUSTOMER RESPONSE: BLOOD LEAKS FROM THE ISOLATION WHERE THE NEEDLE CORE IS WITHDRAWN AND THE NEEDLE TIP GUARD CANNOT BE ACTIVATED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20925627 ↗MalfunctionOct 21, 2024Material Rupture; Material Rupture
22-OCT-2024: RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION. IN REFERENCE TO DOT POINT 1: THE PATIENT HAD SOFT TISSUE DAMAGE AS THE VEIN BLEW - THIS BEING THE INDICATION OF A VEIN EXTRAVASATION. IT IS WHERE THE CONTENT OF CONTRAST/N SALINE LEAKS INTO THE SURROUNDING TISSUES AND FORM A RAISED LUMP. IN REFERENCE TO DOT POINT 2: THE CLAMP WAS UNCLAMPED. THIS IS TESTED AND ENSURED PRIOR TO SCAN. THIS ALSO IS SUPPORTED BY THE VEIN EXTRAVASATION. WITH THIS, THE PRESSURE THE RADIOGRAPHER SET FOR CONTRAST INJECTION MAY HAVE BREACHED THE LINES LIMIT. IN REFERENCE TO DOT POINT 3: SEE REFERENCE TO DOT POINT 1 AS BOTH COME UNDER THE SAME CATEGORY. WITH THIS INCIDENT CONTRAST WAS ALSO NOTED ON THE SURFACE OF THE PATIENTS SKIN AS WELL. IN TOTAL: VISUAL OUTSIDE SKIN WAS NOTED WITH LEAKED CONTRAST, AND INTERNAL SOFT TISSUE DAMAGE (EXTRAVASATION) IN ADDITION WITH THE BLOWN EXTENSION LINE AS NOTED BY THE PICTURES AND REPORT.
Patient problems: Extravasation
MAUDE report 20495635 ↗MalfunctionAug 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN USED IN THE RADIOTHERAPY DEPARTMENT, THE INFUSION CONNECTOR LEAKED AND THE DEFECTIVE PRODUCT COULD NOT BE RETURNED, A CLAIM WAS REQUIRED, A COMPLAINT RESPONSE LETTER WAS REQUIRED, AND A COMPLAINT RECEIPT LETTER WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20081091 ↗MalfunctionApr 8, 2024Material Separation; Material Separation
CANULLA AS INSERTED IN PATIENT 3 DAYS AGO, THE NEXIVA FLEXIBLE TUBING HAS SEPARATED FROM THE WINGS OF THE CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19066387 ↗
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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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