BD Nexiva 383556Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20 GA X 1.00IN SP WITH MAXZERO · Class 2
Quick summary
This BD Nexiva intravenous catheter is a thin plastic tube placed in a vein to give fluids or medicine. Many of the 113 reports describe fluid or blood leaking or splashing, the needle safety feature being difficult or slow to activate, and the device becoming contaminated or separating. The reports record no injuries and no deaths, and 15 note no consequences to the patient. 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
- 103
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00382903835560), received between Oct 20, 2017 and Sep 29, 2026 — classified as 103 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (27 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/Splash27
- Difficult or Delayed Activation11
- Fluid/Blood Leak11
- Device Contamination with Chemical or Other Material8
- Break6
- Material Separation6
- Material Split, Cut or Torn5
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient15
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Pain2
- Exposure to Body Fluids1
- Foreign Body In Patient1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932697 ↗MalfunctionSep 9, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696491 ↗MalfunctionJun 29, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA MAXZERO LEAKED AT THE SEPTUM. VERBATIM: ¿INT, 20 GAUGE, REFERENCE NUMBER (B)(4), LOT NUMBER 6071024 IS LEAKING FROM THE NEEDLE DISCONNECTION HUB. DUE TO THIS THE HARD TO STICK PATIENT HAD TO BE STUCK TWICE. AFTER TALKING TO OTHER STAFF MEMBERS THIS HAS BEEN HAPPENING A LOT WITH THIS BATCH OF INTS.¿ 22-JUN-2026: WHAT WAS THE IMPACT TO THE PATIENT? THE INT HAD TO BE REPLACED DUE TO LEAKAGE, REQUIRING AN ADDITIONAL VENIPUNCTURE. NO FURTHER PATIENT HARM OR COMPLICATIONS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653271 ↗MalfunctionJun 26, 2026Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA MAXZERO TUBING WAS DEFECTIVE OR BECAME DAMAGED. THEY STATED A NEXIVA 20G EXTENSION TUBING COLLAPSED DURING POWER INJECTION. (B)(6) 2026 PATIENT HAD TO GET A NEW IV PLACED AND CT SCAN HAD TO BE RE-RUN, NO OTHER PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637146 ↗MalfunctionJun 11, 2026Fluid/Blood Leak
THEY HAD A NEXIVA CATHETER NOT FUNCTION PROPERLY ON (B)(6) 2026. THEY SAID THE GREY PIECE CIRCLED IN THE IMAGE BELOW DID NOT SEAL ONCE THEY PULLED THE NEEDLE OUT, WHICH CAUSED BLOOD TO LEAK AROUND IT. PRODUCT SKU 383556, LOT NUMBER 6071024. HAVE YOU HAD REPORTS OF THIS FROM OTHER CUSTOMERS? THE PATIENT HAD TO GET A NEW IV PLACED. NO PATIENT HARM WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476346 ↗MalfunctionMay 11, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138227 ↗MalfunctionApr 29, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031579 ↗MalfunctionApr 29, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028587 ↗MalfunctionApr 29, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028586 ↗MalfunctionApr 2, 2026Material Separation; Material Integrity Problem
MalfunctionMar 20, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. ONE OF OUR ED TECH WAS PLACING AN IV NOTICED THAT WHEN HE WAS INSERTING THE CATHETER THE NOTCH THAT GIVES US A FLASH SPLINT IN HALF. PATIENT REQUIRED NEW IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651262 ↗MalfunctionJan 20, 2026Leak/Splash; Material Split, Cut or Torn
THEY HAD AN ISSUE WITH A 20 GAUGE NEXIVA WHERE AFTER CT POWER INJECTION THE EXTENSION TUBING WAS LEAKING WHERE IT CONNECTS TO THE STABILIZATION DEVICE. 6 JAN CUSTOMER RESPONSE: DATE OF EVENT: 12/31/25. PATIENT IMPACT: IV HAD TO BE REMOVED AND THE PATIENT HAD TO GET NEW IV ACCESS FLUID USED: ISOVUE AND SALINE. NO PICTURES WERE TAKEN AT THE TIME AND THE ANGIOCATH WAS THROWN AWAY. THE TUBING ACTUALLY SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24124175 ↗MalfunctionJan 15, 2026Fluid/Blood Leak; Material Separation
BRIEF DESCRIPTION OF INCIDENT: PT HAD NSL FOR CT - WAS INFUSING (MESS AND FLUSH). DURING INFUSION OF CONTRAST NSL PLUG/PLUNGER POPPED OUT OF ANGIOCATH. BLOOD AND CONTRAST RELEASED ONTO PT GOWN. CUSTOMER RESPONSE ON 05-JAN-2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 23-12-2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE MALFUNCTION OCCURRED DURING CT CONTRAST INFUSION, EXPOSURE TO BLOOD AND BODILY FLUIDS, CONTRAST. THE RATE USED (5.5ML/SEC) IS APPROPRIATE FOR A PE STUDY USING OMNIPAQUE 300 AND A 20G SINGLE PORT NEXIVA CATHETER (POSTER ATTACHED). A SPIKE IN PRESSURE IS NOTED ON THE GRAPH IN THE SUMMARY. IT DOES NOT APPEAR THAT THE INJECTION WAS ABORTED SO THIS COULD BE DUE TO A CHANGE IN ARM POSITION. THERE IS SOME DOCUMENTATION ABOUT PATIENT COOPERATION SO I AM WAITING TO SPEAK TO THE PRIMARY TECHNOLOGIST TO GET MORE INFORMATION. IF I GATHER ANY MORE INFORMATION THAT WOULD BE BENEFICIAL TO THE TEAM, I WILL BE SURE TO SHARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079426 ↗MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433354 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS OCCURRED ON (B)(6) 2025. WE HAD ANOTHER INSTANCE OF BLOOD LEAKING FROM THE END OF THE IV CATHETER ON PRODUCT 383556. THIS CAUSED THE PATIENT TO BE STUCK A SECOND TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853244 ↗MalfunctionAug 14, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT BD NEXIVA MAXZERO OPEN PACKAGE SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS OPENED/EXPOSED WITH A BLACK STRIP OF TAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806862 ↗MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED FROM THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECEIVED THIS INFORMATION FROM XXX IN AND EMAIL AND THE ATTACHED PICTURE WAS SENT ALSO. WE HAVE HAD TWO OF THIS PRODUCT LEAKS IN THE LAST 2 DAYS. THE ADDITIONAL UNITS RETURNED WERE DUE TO SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22497812 ↗MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED FROM THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECEIVED THIS INFORMATION FROM XXX IN AND EMAIL AND THE ATTACHED PICTURE WAS SENT ALSO. WE HAVE HAD TWO OF THIS PRODUCT LEAK IN THE LAST 2 DAYS. 07/07/2025 1. WAS THERE ANY HARM/SERIOUS INJURY TO THE PATIENT DIRECTLY RELATED TO THE REPORTED EVENT? NO HARM DONE TO THE PATIENTS 2. PLEASE CONFIRM THE NUMBER OF DIFFERENT PATIENTS IMPLICATED IN THIS REPORTED EVENT. 3 PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493986 ↗MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493985 ↗MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION 07/07/2025. 1. WAS THERE ANY HARM/SERIOUS INJURY TO THE PATIENT DIRECTLY RELATED TO THE REPORTED EVENT? NO HARM DONE TO THE PATIENTS. 2. PLEASE CONFIRM THE NUMBER OF DIFFERENT PATIENTS IMPLICATED IN THIS REPORTED EVENT. 3 PATIENTS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22411136 ↗MalfunctionJun 18, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286894 ↗MalfunctionMay 5, 2025Leak/Splash; Leak/Splash
MATERIAL: 383556 LOT: 4218833 IT WAS REPORTED BY CUSTOMER THAT NEXIVA FEELS DULL, PAINFUL FOR PATIENTS, LEAKS AT SITE, DIFFICULT TO SECURE WITH THE WINGS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CONCERN DESCRIPTION: FEELS DULL, PAINFUL FOR PTS, LEAKS AT SITE, DIFFICULT TO SECURE WITH THE WINGS.
Patient problems: Pain
MAUDE report 21965081 ↗MalfunctionFeb 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO FOREIGN MATTER VS MANUFACTURING DEFECT ON CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL PLASTIC DEBRIS OR A MANUFACTURING DEFECT AT THE END OF THE CATHETER. IT WAS NOT USED ON A PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413764 ↗MalfunctionFeb 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO FOREIGN MATTER ON CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLEXIBLE PLASTIC CATHETER PORTION OF NEXIVA 20G INTRA VENOUS OBSERVED TO HAVE VISIBLE DEFECT / DEBRIS LEFT ON OUTSIDE OF CATHETER. LOT: 4178020. CUSTOMER RESPONSE RECEIVED ON 03-FEB-2025. THE DEFECT WAS OBSERVED BEFORE THE PRODUCT WAS USED FOR PATIENT CARE, SO THERE WAS NO HARM OR NEGATIVE OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21406766 ↗MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.00IN SP WITH MAXZERO SEPARATION ADAPTER FROM TUBING. IT WAS REPORTED BY CUSTOMER THAT THEY ARE SEEING INCREASED NUMBERS OF THE TUBING DETACHING FROM THE DEVICE. VERBATIM: ARE YOU LOOKING AFTER THE IV NEXIVA CATHETERS, WE ARE SEEING INCREASED NUMBERS OF THE TUBING DETACHING FROM THE DEVICE. I WILL ATTACH PICTURE. WE HAVE TO FILL XXX AND PRODUCT COMPLAINT FORMS. LET ME KNOW IF YOU ARE AWARE OF ANY ISSUES. YES, 20 AND 22 AS FAR AS I KNOW, AND MORE FREQUENTLY LATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355950 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
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- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.