BD Nexiva 383519Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18 GA X 1-1/4 IN SINGLE PORT · Class 2
All models of BD Nexiva (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva IV catheter is a short-term intravascular catheter. Its 155 reports mostly describe fluid or blood leaking at the catheter and tubing connections, along with cracks in the tubing and the catheter separating from its hub during removal. The reports include no deaths and 5 injuries, and 150 are malfunctions. No recalls name this device. Reports dropped from 47 in the year before to 20 in the latest year.
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
- 151
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00382903835195), received between Nov 15, 2017 and Jun 17, 2026 — classified as 5 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (53 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/Splash53
- Fluid/Blood Leak47
- Break13
- Defective Component12
- Material Separation6
- Detachment of Device or Device Component4
- Component Missing3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- No Known Impact Or Consequence To Patient29
- Insufficient Information14
- No Consequences Or Impact To Patient10
- Hemorrhage/Blood Loss/Bleeding3
- Pain3
- Discomfort2
- No Code Available2
Recent adverse event reports
The 25 most recent of 151 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Leak/Splash; Material Integrity Problem
EVENT DETAILS: I WENT TO DO AN IV FOR A CT EXAM. I PULLED BACK ON IV TO PREPARE IT FOR EXAM. IT DID FEEL A BIT STIFF AND NOT AS SMOOTH AS USUAL. HOWEVER, I DID PROCEED WITH THE POKE. THE IV WENT IN OK BUT ONCE I HAND FLUSHED WITH 10ML OF SALINE IT FELT A BIT DIFFICULT TO FLUSH AND BLOOD APPEARED BEHIND THE WINGS. PT. SAID IT FELT OK. I THEN PROCEEDED TO TRY A POWER INJECTOR FLUSH, AND IT IMMEDIATELY PRESSURED OUT. THERE APPEARED TO BE A CRACK OR SOMETHING WRONG WITH THE IV. REMOVED AND RESTARTED WITH A NEW IV IN THE OTHER ARM. NO APPARENT HARM - REACHED THE PATIENT/PERSON- INCONVENIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25539595 ↗MalfunctionJun 16, 2026Contamination
VERBATIM: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: FOREIGN MATERIAL IN THE TUBING OF A NEXIVA SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524193 ↗MalfunctionJun 8, 2026Break
IV TECHNICIAN REMOVED THE 18G IV FROM THE PATIENT AND THE IV CATHETER SEPARATED FROM THE HUB COMPLETELY. LUCKILY NO PART OF THE IV CATHETER WAS LEFT IN THE PATIENT. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NEW IV NEEDED TO BE PLACED SINCE THE DEVICE WAS FAULTY WHICH IS POOR CUSTOMER SERVICE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430562 ↗MalfunctionJun 4, 2026Leak/Splash
DURING USE, FLUID LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CANNULA HUB. ONE UNIT WAS DEFECTIVE; THE DEFECTIVE PRODUCT CANNOT BE RETURNED. PHOTOGRAPHIC EVIDENCE IS AVAILABLE. WE REQUIRE A CLAIM SETTLEMENT, A RESPONSE LETTER TO THE COMPLAINT, AND A RECEIPT OF COMPLAINT ACKNOWLEDGMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402252 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT THE IV LEAKED AT THE SEPTUM. (B)(6) 2026 - AFTER SUCCESSFUL PLACEMENT, THE IV SYSTEM LEAKED OUT THE PORTAL OF ENTRY AFTER THE NEEDLE WAS REMOVED. A NEW IV NEEDED TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230072 ↗MalfunctionMay 20, 2026Fluid/Blood Leak
I WAS REPORTED THAT LEAKAGE OCCURRED. UPON REPORT FROM THE IV TECH, UPON INSERTION OF THE IV, BLOOD LEAKED FROM THE CONNECTION AREA WHERE THE NEEDLE IS SUPPOSED TO BE REMOVED FROM. THE IV HAD TO BE REMOVED AND A NEW IV PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230054 ↗MalfunctionMay 19, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25223042 ↗MalfunctionMay 19, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25223040 ↗MalfunctionMay 15, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182574 ↗MalfunctionMar 20, 2026Fluid/Blood Leak; Leak/Splash
NO NEW INFORMATION.
Patient problems: Distress; Hemorrhage/Blood Loss/Bleeding
MAUDE report 24650671 ↗MalfunctionMar 8, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541725 ↗MalfunctionMar 2, 2026Material Integrity Problem
IT WAS REPORTED THAT HUB AND TUBE ROOT WAS DAMAGED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481826 ↗MalfunctionFeb 20, 2026Contamination
IT WAS REPORTED THAT CUSTOMER RECEIVED 1 PACK WHICH ARE BLACK/DIRTY. LOOKS LIKE THERE IS INK OR OTHER DIRT LIKE SOOT OR SMUT. ADDITIONAL INFORMATION FROM MAIL RECEIVED ON 12 JAN 2026. VISIBLE CONTAMINATION BY BLACK PARTICLES IN THE SEALED STERILE TRANSPARENT PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402072 ↗MalfunctionFeb 3, 2026Leak/Splash
LEAKAGE AT TUBING CONNECTION IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247791 ↗MalfunctionJan 27, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190686 ↗MalfunctionJan 13, 2026Fluid/Blood Leak
INCIDENT DETAILS: WRITER WAS STARTING IV. IV MALFUNCTION. BLOOD STARTED POOLING OUT OF BOTTOM. SERIOUS INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059205 ↗MalfunctionJul 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PREOP SURGERY PREP, PATIENT WAS POKED MULTIPLE TIMES DUE TO EQUIPMENT MALFUNCTIONING. TWO BD NEXIVA 18G IV CATHETERS LEAKED BLOOD FROM THE BACK OF THE IV HUB WHEN PLACED INTO THE PATIENTS VEIN. WHEN THE RN TRIED TO ASPIRATE, THE IV PULLED AIR AS THE HUB WAS NOT SEALED FROM THE MANUFACTURER. BOTH IVS CAME FROM THE SAME LOT NUMBER. UPON THE THIRD ATTEMPT, THE IV FUNCTIONED AS DESIGNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22549395 ↗MalfunctionJul 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INSERTING THE IV, THE BACKFLOW STOP DID NOT WORK, CAUSING BLOOD TO FLOW OUT OF THE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22513094 ↗MalfunctionJul 2, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22386177 ↗MalfunctionJun 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: (B)(6) 2025. LEVEL OF HARM: MINIMAL HARM. INCIDENT DETAILS: AFTER WITHDRAWING IV INITIATION NEEDLE INTO THE SAFETY DEVICE, THERE WAS A SUDDEN BACK FLOW OF BLOOD OUT OF PORT WHERE NEEDLE IS PULLED BACK THROUGH. IMPACT OF INCIDENT: DELAY TO TREATMENT/THERAPY. WHO WAS AFFECTED? PATIENT.
Patient problems: Discomfort; Insufficient Information
MAUDE report 22130999 ↗MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED FROM THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 AFTER SUCCESSFUL PLACEMENT INTO A PATIENT'S VEIN THE NEEDLE PIECE WAS REMOVED AND BLOOD LEAKED OUT THE BACK. THE SYSTEM WAS REMOVED AND A NEW IV PLACED INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081114 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969937 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969922 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969917 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969912 ↗
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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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