BD Nexiva Diffusics 383592Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS 20G X 1.00 IN · Class 2
Quick summary
This BD Nexiva Diffusics is a short-term IV catheter, a thin plastic tube placed in a vein to give fluids or medicines. Reports mostly describe leaking or spraying fluid, cracks or breaks in the tubing, and brown-like residue found on the tip before or during use. There are 45 reports, including 1 death and 1 injury; most report no patient harm. 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
- 43
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00382903835928), received between Dec 7, 2017 and Mar 3, 2026 — classified as 1 death, 1 injury, 41 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash9
- Break5
- Device Contamination with Chemical or Other Material5
- Difficult or Delayed Activation3
- Material Integrity Problem3
- Defective Component2
- Defective Device2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient4
- Foreign Body In Patient2
- Air Embolism1
- Cardiac Septal Defect Residual Shunt1
- Exposure to Body Fluids1
- Extravasation1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497472 ↗MalfunctionFeb 10, 2026Material Integrity Problem; Insufficient Device Problem Information
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304941 ↗DeathOct 30, 2025Therapeutic or Diagnostic Output Failure; Air/Gas in Device
PATIENT WAS ADMITTED TO THE ED, AND A 20GA IV CATHETER WAS PLACED IN THE RIGHT FOREARM. THE PATIENT WAS, THEN, TRANSFERRED TO IMAGING TO RECEIVE A CT WITH CONTRAST, AND THE PREVIOUSLY PLACED 20GA IV CATHETER WAS CONNECTED TO THE CONTRAST INJECTOR. WHILE IN THE ED AND TWO HOURS AFTER THE INITIAL CT, THE PATIENT BEGAN TO DETERIORATE AND WAS BROUGHT BACK TO IMAGING FOR A HEAD CT WITHOUT CONTRAST. AN AIR EMBOLISM WAS CONFIRMED. PATIENT RETURNED TO ED, TWO ADDITIONAL IVS WERE PLACED (18GA-LEFT FOREARM AND 20GA-RIGHT ANTECUBITAL), DOCTOR INTUBATED THE PATIENT, AND THE PATIENT WAS LATER TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) A FEW HOURS LATER. WHILE IN THE CCU, THE PATIENT RECEIVED A DOPPLER TO CONFIRM A DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT ARM AND REPEAT CT SCANS WITHOUT CONTRAST OF THE HEAD. ADDITIONALLY, MEDICAL STAFF DISCOVERED A RIGHT TO LEFT SHUNT WHILE RECEIVING A ECHOCARDIOGRAM. PATIENT WAS EXTUBATED AND PLACED ON HIGH-FLOW OXYGEN BUT SHOWED SIGNS OF DEFICIT ON THE LEFT SIDE OF THE BODY. NEUROLOGY CONFIRMED A RIGHT-SIDED LARGE TERRITORY CEREBROVASCULAR ACCIDENT (CVA) DUE TO THE PRESENCE OF AN AIR EMBOLISM. PATIENT HAD NASOGASTRIC (NG) TUBES CONNECTED. THE REPORTING FACILIT
Patient problems: Air Embolism; Cardiac Septal Defect Residual Shunt; Feeding Problem; Low Oxygen Saturation; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 23423807 ↗MalfunctionSep 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN - 383592 - FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BROWN-LIKE RESIDUE LOCATED ON THE TIP OF THESE CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993219 ↗MalfunctionSep 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN - 383592 - FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BROWN-LIKE RESIDUE LOCATED ON THE TIP OF THESE CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993194 ↗MalfunctionAug 20, 2025Defective Device; Defective Device
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN - CATHETER DEFECTIVE / DAMAGED / LEAKAGE IT WAS REPORTED BY THE CUSTOMER THAT AFTER STARTING AN IV ON A PATIENT THIS AFTERNOON THEY NOTICED A SMALL DROP OF BLOOD ON HER ARM. AS THEY PROCEEDED TO FLUSH THE IV IT SPRAYED OUT OF A SMALL HOLE IN THE SIDE OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853250 ↗MalfunctionAug 20, 2025Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN - CATHETER DEFECTIVE / DAMAGED. VERBATIM: THIS IS FROM THE RN: GOOD MORNING, I'M SO SORRY FOR THE DELAY I HAVE BEEN AWAY ON VACATION FOR BACK TO SCHOOL - I PREPPED THE PATIENT IN USUAL FASHION AFTER STERILIZING AREA I APPLIED TOURNIQUET PT HAD BEAUTIFUL EASILY ACCESSIBLE VEINS AND PATIENT LAID STILL DURING ENTIRE PROCEDURE WHEN I STUCK HIS LEFT AC I GOT FLASH AND STARTED TO ADVANCE CATHETER BLOOD STARTED LEAKING COMPLETELY AROUND THE IV AND NOT IN THE CATHETER I CONTINUED TO ATTEMPT TO ADVANCE AND WITHDRAW NEEDLE IN WHICH IT WAS THEN MADE OBVIOUS THE CATHETER ITSELF WAS FRACTURED- I PULLED EVERYTHING FROM SITE THEN HAD TO MANUALLY MANIPULATE THE SMALL FRACTURED PIECE OUT OF THE VESSEL TO PROTECT THE PATIENT AND PREVENT CATASTROPHIC INJURIES . I WAS ABLE TO DO THIS SUCCESSFULLY AT WHICH I PLACED A PRESSURE DRESSING AND THEN NOTIFIED CHAIN OF COMMAND OF WHAT HAD HAPPENED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22851742 ↗MalfunctionMay 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS TUBING SEPARATED FROM THE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE INSERTED A 20G DIFFUSICS AND WHEN SHE STARTED TO FLUSH THE LINE, THE EXTENSION SET DISCONNECTED. PATIENT HAD TO BE STUCK AGAIN. WE ARE NOT AWARE OF ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037662 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767159 ↗MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21213668 ↗MalfunctionNov 7, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627201 ↗MalfunctionOct 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502030 ↗MalfunctionOct 9, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN NEEDLE THROUGH CATHETER IT WAS REPORTED BY CUSTOMER THAT PIV MALFUNCTIONED AND NEEDLE WENT THROUGH ANGIOCATH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE: 09/13/2024 PIV MALFUNCTIONED AND NEEDLE WENT THROUGH ANGIOCATH. PATIENT NEEDED TO BE RESTUCK FOR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20411969 ↗MalfunctionSep 18, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT BD NEXIVA DIFFUSICS 20G CLOSED IV CATHETER SYSTEM USED TO START IV ON PT FOR CONTRAST ADMINISTRATION DURING CT SCAN, UNABLE TO USE INITIAL SITE AS CATHETER WAS FAULTY, HAVING HOLES IN CATHETER ON PROXIMAL END INSTEAD OF JUST DISTAL END WHERE THEY'RE DESIGNED TO BE, CAUSING IV TO LEAK AND PT TO BLEED FROM IV SITE WHILE IV WAS STILL INSERTED. SECOND IV STARTED ON PT WITHOUT COMPLICATIONS. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED BD NEXIVA DIFFUSICS 20G CLOSED IV CATHETER SYSTEM USED TO START IV ON PT FOR CONTRAST ADMINISTRATION DURING CT SCAN, UNABLE TO USE INITIAL SITE AS CATHETER WAS FAULTY, HAVING HOLES IN CATHETER ON PROXIMAL END INSTEAD OF JUST DISTAL END WHERE THEY'RE DESIGNED TO BE, CAUSING IV TO LEAK AND PT TO BLEED FROM IV SITE WHILE IV WAS STILL INSERTED. SECOND IV STARTED ON PT WITHOUT COMPLICATIONS. NO COMPLICATIONS REQUEST A RETURN LABEL-PLEASE E-MAIL TO ME. (B)(6). NEXIVA DIFFUSICS IV CATHETER SAMPLE WILL BE SENT BY CUSTOMER EMAIL UNKNOWN OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20253017 ↗MalfunctionAug 12, 2024Defective Component; Defective Component
MalfunctionApr 26, 2024Break; Break
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.00 IN CATHETER BROKE / SEPARATED AFTER PLACEMENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DIFFUSICS IV CATHETER SHEARED OFF INTO PATIENTS ARM. VERBATIM: DIFFUSICS IV CATHETER SHEARED OFF INTO PATIENTS ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197253 ↗MalfunctionApr 25, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS NEEDLE DID NOT COMPLETELY SEPARATE FROM CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ATTEMPTED IV START AND NEEDLE WOULD NOT COMPLETELY RETRACT FROM IV CATHETER, CAUSING PT TO HAVE TO BE STUCK AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183569 ↗MalfunctionMar 28, 2024Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS NEEDLE DID NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV INSERTION PATIENT REQUIRED TWO IVS RELATED TO A HIGH HEART RATE AND SEDATION PROCEDURE. DURING INSERTION OF 2ND IV, THE IV WITH INSERTED AND UPON RECEIVING A FLASH OF BLOOD, THE CATHETER WAS BEING THREADED WHILE WITHDRAWING THE NEEDLE, DURING WITHDRAWL OF THE NEEDLE APPROXIMAETLY 0.5" OF THE NEEDLE WOULD WITHDRAW BUT IT WOULD NOT WITHDRAW/DISENGAGE FROM DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997563 ↗MalfunctionFeb 16, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18722642 ↗MalfunctionJan 26, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
RESPONSE RECEIVED. 0N 24TH JAN 24. THANKS FOR FOLLOWING UP. I¿M INCLUDING LILIANA TO THIS EMAIL CHAIN WHO CAN HELP ASSIST WITH YOUR QUESTIONS. LILI ¿ THIS IS THE TEAM WHO IS INVESTIGATING THE PRODUCT CONCERN REGARDING THE IV CATHETER. CAN YOU HELP ANSWER THE QUESTIONS BELOW? HELLO, 1. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THERE WAS NO HEALTH CONSEQUENCES, PATIENT HAD TO BE POKED SEVERAL MORE TIMES DUE TO THIS PRODUCT MALFUNCTION, BUT SHE WAS NOT AFFECTED OTHERWISE. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO. 3. ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? THIS IS THE HOSPITAL'S ADDRESS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18587908 ↗MalfunctionJan 5, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18454740 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WENT TO THE BATHROOM, WIPED AND THE IV SNAPPED AT THE CATHETER HUB LEAVING THE CATHETER IN THE PATIENT¿S VEIN. ADDITIONAL INFORMATION RECEIVED ON 16-JULY-2023 I WAS OUT OF THE OFFICE SICK LAST WEEK. SEE BELOW PRODUCT COMPLIANT FROM ST JOES IN BELLINGHAM, WA. CONTACT IS MICHELLE HENDERSON. ST. JOE¿S RECENTLY HAD AN INCIDENT WITH THE BD DIFFUSICS 20G CATHETER, LOT# 308803. THE PATIENT WENT TO THE BATHROOM, WIPED AND THE IV SNAPPED AT THE CATHETER HUB LEAVING THE CATHETER IN THE PATIENT¿S VEIN. PRODUCT WAS NOT KEPT FOR REVIEW. I WOULD LIKE TO SUBMIT A FORMAL CONCERN RELATED TO THIS. HAVE THERE BEEN REPORTS OF LIKE OCCURRENCE OR LOT ISSUES REPORTED?
Patient problems: Foreign Body In Patient
MAUDE report 17421331 ↗MalfunctionDec 7, 2022Leak/Splash; Defective Device; Leak/Splash; Defective Device
IT WAS REPORTED BY THE CUSTOMER THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM SPRAYED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PLACING THE CATHETER, RN WAS PULLING BACK THE NEEDLE AND WHILE DOING SO BLOOD CAME OUT AND SPRAYED RN IN THE CHEST.
Patient problems: Exposure to Body Fluids
MAUDE report 15936375 ↗MalfunctionNov 21, 2022Material Discolored; Material Discolored
IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOLORATION OF THE TIP OF THE DIFFUSICS CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840582 ↗MalfunctionJul 22, 2022Material Discolored; Material Discolored
IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER, TIP IS DISCOLORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090052 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.