BD Nexiva 383552Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 22 GA X 1.00IN SP WITH MAXZERO · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva short-term IV catheter has 82 adverse event reports, with no deaths and 2 injuries. Reports mostly describe fluid or blood leaking from the catheter and tubing coming apart; no recalls name this device. Reports dropped from 15 in the previous 12 months to 3 in the past 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
- 84
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00382903835522), received between Nov 10, 2017 and Sep 24, 2026 — classified as 2 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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/Splash21
- Fluid/Blood Leak18
- Material Puncture/Hole7
- Material Separation7
- Difficult or Delayed Activation5
- Break3
- Defective Component3
- Material Protrusion/Extrusion3
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Insufficient Information9
- No Known Impact Or Consequence To Patient8
- Hemorrhage/Blood Loss/Bleeding2
- Air Embolism1
- Foreign Body In Patient1
- Hematoma1
- Injury1
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Puncture/Hole
It was reported that BD NEXIVA needle pierced the catheter. The catheter kinked while in situ in the patient, resulting in catheter occlusion. Additional information 18 Sep 2026: No Patient harm of user harm is known to have occurred.Based on the images received, it appears that the needle may have been partially withdrawn during catheter insertion and subsequently advanced again. As a result, it is possible that the catheter was punctured by the needle. I also wonder whether the user is familiar with Instaflash and its intended use during insertion.I have offered additional training and clinical support to the involved department to review device use and help prevent similar events in the future. Emma indicated that se would like to make use of this training opportunity.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884816 ↗MalfunctionSep 23, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873048 ↗MalfunctionSep 9, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700902 ↗MalfunctionApr 28, 2026Material Separation
NO NEW INFORMATION.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 25020954 ↗MalfunctionFeb 9, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT BLOOD LEAKING FROM MULTIPLE SPOTS ON CANNULA. DESCRIBE PATIENT /(HCP) / USER IMPACT: NONE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293524 ↗MalfunctionSep 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
DATE OF INCIDENT: ON (B)(6) 2025 CONCERN DESCRIPTION: INSERT AN IV INTO A PATIENT AND ON VISUAL INSPECTION NOTICED BROWN/GREY MATERIAL IN THE IV PORT/TUBE. THE SUBSTANCE MAY HAVE BEEN MOLD OR DIRT, BUT IT WAS DIFFICULT TO TELL AS IT WAS INSIDE THE DEVICE. THE DEVICE WAS PREVIOUSLY SEALED. AS PER THE RN AND PSLS, THERE WAS NO PATIENT HARM, INJURY OR COMPLICATION. THIS WAS CAUGHT BEFORE IT REACHED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015973 ↗MalfunctionJul 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT HAD IV FOR APPROXIMATELY 1 HOUR. PATIENT REPORTED IV LEAKING. NURSE ASSESSED PATIENT FOR SITE LEAKAGE. IT WAS NOTED THAT THE PIGTAIL SECTION WAS LEAKING FLUID. NURSE REMOVED IV CATHETER AND FURTHER ASSESSED IT. WHEN FLUSHING THERE WAS VISIBLE FLUID LEAKAGE COMING OUT OF THE PIGTAIL. REQUIRED INTERVENTION (NOT DEFINED).
Patient problems: Insufficient Information
MAUDE report 22407394 ↗MalfunctionJun 25, 2025Premature Separation; Premature Separation
ADDITIONAL INFORMATION 1. COULD YOU PLEASE CONFIRM THE STATEMENT "3X HAPPENED AT 1.5 MONTHS" ARE THESE 3 OCCURRENCES OVER 1.5 MONTHS OR IS 3 OCCURRENCES ON A 1.5-MONTH-OLD PATIENT. = THREE OCCURRENCES OVER 1,5 MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330555 ↗MalfunctionJun 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236668 ↗MalfunctionMay 30, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING SEPARATED FROM ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PIPE CAME LOOSE WHILE IT WAS ATTACHED TO A PATIENT. FORTUNATELY, A NURSE WAS NEARBY, AND IT ENDED WELL. HOWEVER, CAN YOU HAVE A CHECK IF THIS WAS AN ISOLATED CASE, OR IF THERE COULD HAVE BEEN A MANUFACTURING DEFECT SOMEWHERE? WAS PATIENT OR USER HARMED? NO, NOT IN THE END. BECAUSE A NURSE WAS NEARBY IN TIME, SHE WAS ABLE TO RESOLVE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119561 ↗MalfunctionApr 28, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21923182 ↗MalfunctionMar 25, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689766 ↗MalfunctionMar 21, 2025Material Separation; Separation Problem; Material Separation; Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21668126 ↗MalfunctionFeb 25, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462121 ↗MalfunctionFeb 13, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING SEPARATED FROM THE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA EXTENSION TUBING COMING DETACHED FROM PIVC. BLOOD EXPOSURE; NEED TO RESTART IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378899 ↗MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21368618 ↗MalfunctionJan 13, 2025Break; Break
IT WAS REPORTED THAT BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO CANULA BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMPLOYEE FROM TRANSPORT ALERTED RN THAT IV HAD BECOME DISCONNECTED. ON EXAM BY RN, CANULA BELLOW CLAVE WAS FOUND IN TWO PIECES BROKEN BELLOW CLAVE W/ CLAMP INTACT. NO BLEEDING. IV REMOVED AND IV TEAM MADE AWARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21146033 ↗MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: (B)(6) 2024. ON (B)(6) 2024 CONCERN DESCRIPTION: DIFFICULT TO USE MAX ZEROS ARE FILLING WITH MEDICATION AND BLOOD. OCCURRENCES: 1 EA. ON (B)(6) 2024. YES, WHEN THE NURSES GO TO ADMINISTER PROCEDURAL SEDATION, THEY GET FLUIDS ON THEIR HANDS AFTER TOUCHING THE MAX ZERO TO PUSH DRUGS. IT IS POSSIBLE THAT THIS FLUID IS RESIDUAL SALINE AND BLOOD CAUGHT IN THE RUNGS/THREADS OF THE MAX ZERO CONNECTION. HOWEVER, THE NURSES AND PHYSICIANS ARE UPSET WITH IT. AND IT IS CONCERNING. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20761034 ↗MalfunctionNov 7, 2024Activation Problem; Activation Problem
IT WAS REPORTED THAT BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO SAFETY MECHANISM / NEEDLE DISENGAGEMENT DIFFICULT. IT WAS REPORTED BY CUSTOMER THAT IF IV INSERTION IS UNSUCCESSFUL THE NEEDLE HAS TO BE PULLED OUT FROM THE PATIENT AND IS DIFFICULT TO PUT THE SAFETY OVER THE NEEDLE OFTEN REQUIRING TWO HANDS BUT WHILE ALSO GIVING PRESSURE TO THE IV SITE. IT IS AWKWARD IT INCREASES RISK OF NEEDLESTICK INJ, RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION: PRODUCT CODE: 383552. PRODUCT DESCRIPTION: CATHETER IV CLOSED NEXIVA SYST 22G AND X 1IN SP W/MAX ZERO BX/20 P84. LOT/SERIAL #: UNKNOWN. EXPIRY DATE: UNKNOWN. PROBLEM INFORMATION PRODUCT CONCERN TICKET NUMBER: (B)(4). DATE OF INCIDENT: ON (B)(6) 2024. CONCERN DESCRIPTION: IF IV INSERTION IS UNSUCCESSFUL THE NEEDLE HAS TO BE PULLED OUT FROM THE PATIENT AND IS DIFFICULT TO PUT THE SAFETY OVER THE NEEDLE OFTEN REQUIRING TWO HANDS BUT WHILE ALSO GIVING PRESSURE TO THE IV SITE. IT IS AWKWARD IT INCREASES RISK OF NEEDLESTICK INJ OCCURRENCES: 1 EA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627269 ↗MalfunctionNov 4, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLELESS ADAPTER LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONCERN DESCRIPTION: WHEN PUSHING MEDS THROUGH THE NEXIVA IV CATHETER NURSES AND PHYSICIANS ARE BEING EXPOSED TO BLOOD AND MEDICATION AS IT IS LEAKING THROUGH THE MAX ZERO CAP. ALSO A RISK TO THE PATIENT AS THEY MAY NOT BE RECEIVING AN ACCURATE DOSE OF MEDICATION DATE OF INCIDENT: 11-OCT-2024 29 OCT NO VISIBLE DAMAGE TO MAX ZERO CONNECTOR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20605737 ↗MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6)2024 CONCERN DESCRIPTION: BLOOD EXPOSURE AFTER PUSHING IV MEDICATION. BLOOD LEAKING THROUGH MAX ZERO CAP. (ALL CONNECTIONS TIGHT) OCCURRENCES: 1 EA NO ADVERSE EVENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579454 ↗MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557403 ↗MalfunctionOct 29, 2024Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555910 ↗MalfunctionOct 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540989 ↗MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. FIRST OF ALL ON INSERTION THE ¿FILTER¿ WHEN LOOSENED/REMOVED LEAKS BLOOD AS THE COLOURED END BLOCKS THE NURSES ABILITY TO SEE THE BLOOD COMING TO THE END OF THE TUBING. ALSO, DEPENDING ON THE FLOW BACK OF BLOOD SOMETIMES WE DON¿T HAVE TIME TO ¿CLAMP¿ THE TUBING BEFORE BLOOD GETS TO THE VERY END. 2. ANOTHER WAY NURSES ARE GETTING EXPOSURE TO BLOOD FROM THIS PRODUCT IS THROUGH THE IV CAPS. ONCE INSERTED, IF BLOOD WAS OVERFILLED IN THE TUBING IT LEAKS AROUND THE LUER LOCK AND ONCE FLUSHED WITH SALINE OR IVF, THE BLOOD LEAKS OUT FROM THE BOTTOM OF THE CAP. I HAVE ALSO HAD BLOOD LEAK FROM THE TOP PORTION OF THE CAP BOTH ON INSERTION OF IVF/SL AND AFTER REMOVING SL. 3. I HAVE A THIRD WAY SEEN BLOOD EXPOSURE TO NURSES FROM THE BLUNT END, WHERE THE GREY/WHITE HUB GETS REMOVED AFTER INSERTION. THIS IV PRODUCT HAS MULTIPLE BLOOD EXPOSURE AND IS A VERY POOR DESIGN. I WILL BE SUBMITTING ANOTHER PSLS AFTER GETTING BLOOD ON MY HANDS AFTER GIVING IV SEDATION AND FLUSHING WITH SALINE FROM THE BOTTOM OF THE CAP. THIS HAPPENS MULTIPLE CASES A DAY, AND I AM NOT THE O
Patient problems: Insufficient Information
MAUDE report 20510851 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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