BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access 393526Recalls & reported problems
Becton, Dickinson And Company · NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO · Class 2
All models of BD Nexiva Closed IV Catheter System with NearPort IV Access (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva closed IV catheter is a short-term IV line with a needle that retracts after use. The 37 adverse event reports mostly describe leaking or splashing at the site, and needles that did not fully shield the tip when they retracted, plus some contamination, material puncture and product quality issues. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00382903935260), received between May 9, 2024 and Feb 6, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (9 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/Splash9
- Contamination /Decontamination Problem3
- Retraction Problem3
- Activation Problem2
- Deformation Due to Compressive Stress2
- Fluid/Blood Leak2
- Material Integrity Problem2
- Material Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information4
- Pain1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Material Integrity Problem
IT WAS REPORTED BY THE CUSTOMER THAT 20G NEXIVA NEARPORT NEEDLE WAS DEFECTIVE AND DID NOT COVER THE BEVEL OF THE NEEDLE UPON RETRACTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 20G NEXIVA NEARPORT NEEDLE WAS DEFECTIVE AND DID NOT COVER THE BEVEL OF THE NEEDLE UPON RETRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279267 ↗MalfunctionJan 22, 2026
20G NEXIVA NEARPORT NEEDLE WAS DEFECTIVE AND DID NOT COVER THE BEVEL OF THE NEEDLE UPON RETRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144091 ↗MalfunctionNov 21, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619216 ↗MalfunctionNov 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619209 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23509462 ↗MalfunctionNov 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
MATERIAL #393526. LOT #5219889. IT WAS REPORTED BY CUSTOMER THAT SMALL PIECE OF SOMETHING IS ON THE TIP OF THE CATHETER/NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509457 ↗MalfunctionNov 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466638 ↗MalfunctionOct 31, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438165 ↗MalfunctionOct 31, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438156 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380217 ↗MalfunctionSep 18, 2025Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION: NEW IV HAD TO BE ESTABLISHED ON PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23083291 ↗MalfunctionSep 4, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO - 393526 - CATHETER DEFECTIVE / DAMAGED. IT WAS REPORTED BY THE CUSTOMER THAT IV INSERTION ATTEMPTED PLACEMENT UNSUCCESSFUL. UPON REMOVAL OF IV CATHETER, NOTICED TYPE OF IV CATHETER WAS SHREDDED. NO ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962273 ↗MalfunctionAug 18, 2025Difficult to Insert; Material Split, Cut or Torn
IV INSERTION ATTEMPTED PLACEMENT UNSUCCESSFUL. UPON REMOVAL OF IV CATHETER, NOTICED TYPE OF IV CATHETER WAS SHREDDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827173 ↗MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JUST MAKING Y'ALL AWARE IN CASE ANYONE ELSE HAS ANY ISSUES! I INSERTED AN IV ON A PATIENT TONIGHT AND AFTER THE TUBING FILLED WITH BLOOD, A STEADY STREAM OF BLOOD STARTED TO COME OUT OF THE PORT WHERE I DREW AN ARROW COMING OUT OF. I HELD MY FINGER ON IT AT FIRST TO STOP IT, THEN DREW LABS AND FLUSHED IT WITHOUT ANY FURTHER ISSUES. I TOLD (B)(6) ABOUT IT SINCE SHE WAS HERE AND SHE SAID TO MAKE Y'ALL AWARE AS WELL. BLOOD LEAKING OUT OF THE DEAD PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745443 ↗MalfunctionJul 1, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY CUSTOMER THAT 20G NEXIVA NEAR PORT IVS WERE DIFFICULT TO REMOVE OR RETRACT THE NEEDLE UPON INSERTION. VERBATIM: CUSTOMER SHARED THAT THE 20G NEXIVA NEARPORT IVS WERE DIFFICULT TO REMOVE OR RETRACT THE NEEDLE UPON INSERTION. FACILITY SAID THEY HAD SEVERAL INCIDENTS IN THE EMERGENCY DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373699 ↗MalfunctionJun 23, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO NEEDLE RETRACTION FAILED IT WAS REPORTED BY THE CUSTOMER THAT NEXIVA NEAR PORT CATHETER HOUSING WOULD NOT SEPARATE FROM CATHETER. LOCK KEEPING CATHETER IN PLACE DID NOT FULLY DISENGAGE ON INITIAL RETRACTION OF NEEDLE. CATHETER AND GREY PORTION OF HOUSING PRESSED TOGETHER AND THEN CLICK WAS HEARD AND WAS ABLE TO SUCCESSFUL DISENGAGE NEEDLE FROM CATHETER. VERBATIM: NEXIVA NEARPORT CATHETER HOUSING WOULD NOT SEPARATE FROM CATHETER. LOCK KEEPING CATHETER IN PLACE DID NOT FULLY DISENGAGE ON INITIAL RETRACTION OF NEEDLE. CATHETER AND GREY PORTION OF HOUSING PRESSED TOGETHER AND THEN CLICK WAS HEARD AND WAS ABLE TO SUCCESSFUL DISENGAGE NEEDLE FROM CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310216 ↗MalfunctionMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA NEARPORT W/ MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER AN IV IS ESTABLISHED, MEDS OR FLUIDS ARE BEING GIVEN. THE SYRINGE IS HOOKED UP TO THE FAR PORT AND PRESSURE IS APPLIED TO GIVE THE MED. A DISTINCT INCREASE IN RESISTANCE ISN'T NOTICED BY THE NURSE, BUT THE FLUID SHOOTS OUT OF THE NEAR PORT WHEN WE ATTEMPT TO GIVE IT. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEGATIVE OUTCOME CONSISTED OF THE IV CATHETER BEING REMOVED AND A SECOND ONE BEING PLACED. THIS IS AN ADDITIONAL STICK FOR THE PATIENT WHICH IS NEVER IDEAL. IT IS ALSO AN INCREASED COST TO THE HOSPITAL FOR ADDITIONAL SUPPLIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21990682 ↗MalfunctionMar 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO LABEL CONTENT WAS INCORRECT. IT WAS REPORTED BY CUSTOMER THAT THE PALLET OF PRODUCT THAT THEY WERE DISSATISFIED WITH DUE TO MISLABELING OF EXPIRATION DATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. XXXXXX IS DISSATISFIED WITH BD REF NUMBER 393526 LOT NUMBER 4247493 DUE TO MISLABELING, AND IS RETURNING THE PRODUCT FOR FULL CREDIT. THEY ARE RETURNING 84 CASES (1 PALLET) THAT THEY WILL NEED A CREDIT ON. PLEASE ASSIST IN PROCESSING THIS RETURN. I AM CC¿ING MY RBM AND THE PLATFORM MANAGER FOR THIS PRODUCT LINE SHOULD YOU HAVE ANY QUESTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505156 ↗MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO LEAKED AT SEPTUM. IT WAS REPORTED BY CUSTOMER THAT UPON INSERTION OF NEXIVA NEARPORT IV CATHETER BLOOD WAS LEAKING OUT OF SEPTUM WHEN NEEDLE WAS WITHDRAWN AND DETACHED FROM CATHETER. VERBATIM: UPON INSERTION OF NEXIVA NEARPORT IV CATHETER BLOOD WAS LEAKING OUT OF SEPTUM WHEN NEEDLE WAS WITHDRAWN AND DETACHED FROM CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426374 ↗MalfunctionFeb 10, 2025Retraction Problem; Retraction Problem
MalfunctionFeb 3, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY CUSTOMER THAT SAFETY MECHANISM DID NOT FULLY ENGAGE WHEN ATTEMPTING TO REMOVE THE NEEDLE AFTER IV INSERTION. NEEDLE WAS STUCK IN IV AND DID NOT RETRACT/SAFETY. SAFETY MECHANISM DID NOT FULLY ENGAGE WHEN ATTEMPTING TO REMOVE THE NEEDLE AFTER IV INSERTION. NEEDLE WAS STUCK IN IV AND DID NOT RETRACT/SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21293795 ↗MalfunctionJan 13, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143075 ↗MalfunctionJan 7, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095634 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925672 ↗MalfunctionDec 11, 2024Material Deformation; Material Deformation
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904635 ↗
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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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