BD Nexiva 383559Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18 GA X 1.25IN SP WITH MAXZERO · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD Nexiva peripheral IV catheter, a short-term plastic tube placed into a vein for IV access. The 54 reports mostly describe the catheter leaking or splashing fluid, blood leaking from the line, and the material splitting, puncturing, or breaking so the catheter does not hold. Some mention a non-return valve that does not let fluid through and a catheter that failed to seal, sometimes requiring a second stick for IV access. There are no deaths and no injuries, 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00382903835591), received between Feb 19, 2019 and May 18, 2026 — classified as 54 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash27
- Fluid/Blood Leak9
- Material Separation4
- Break3
- Detachment of Device or Device Component3
- Material Puncture/Hole3
- Burst Container or Vessel2
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Known Impact Or Consequence To Patient4
- Exposure to Body Fluids1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
- Pain1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Leak/Splash
MalfunctionMar 18, 2026Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER DID NOT SEAL. BD NEXIVA 18 GA X 1.25 WAS DAMAGED. WHEN THE RN PLACED THE IV, THE LINE WAS NOT SEALED. RN USED ANOTHER BD NEXIVA FROM THE SAME LOT, AND IT WORKED APPROPRIATELY. CUSTOMER RESPONSE (B)(6) 2026: IT IS STATED THAT "BD NEXIVA 18 GA X 1.25 WAS DAMAGED. WHEN THE RN PLACED THE IV, THE LINE WAS NOT SEALED. RN USED ANOTHER BD NEXIVA FROM THE SAME LOT, AND IT WORKED APPROPRIATELY." PLEASE DESCRIBE WHAT IS MEANT BY "THE LINE WAS NOT SEALED" I DO NOT HAVE ADDITIONAL AVAILABLE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626466 ↗MalfunctionFeb 20, 2026Material Puncture/Hole
AFTER ATTEMPTED PLACEMENT, A HOLE WAS SEEN IN THE CATHETER DESCRIBE PATIENT /(HCP) / USER IMPACT PATIENT WAS STUCK AGAIN FOR IV ACCESS OTHER COMMENTS: CATHETER WAS DISCARDED THE HOLE WAS IN THE CATHETER. THE PATIENT HAD TO BE STUCK TWICE DUE TO THE HOLE IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401687 ↗MalfunctionJan 22, 2026Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152860 ↗MalfunctionJan 21, 2026Material Integrity Problem
PROBLEMS WITH THE NON-RETURN VALVE OF PERIPHERAL VENOUS CATHETERS OF THE NEXIVA MODEL. IN CONCRETE TERMS, IT HAS BEEN FOUND THAT THE NON-RETURN VALVES ARE NOT PERMEABLE. RESPONSE RECEIVED ON 1/7/2026: WAS THE DEVICE BEING USED IN/ON THE PATIENT WHEN THE PROBLEM OCCURRED? YES, EVERY TIME HAS THE PATIENT OR USER BEEN HARMED? IF SO, PLEASE EXPLAIN. NO. WERE THE NURSING STAFF PRESENT WHEN THE PROBLEM OCCURRED? YES, EVERY TIME IN CASE OF LEAKAGE, PLEASE CONFIRM THE LEAKED LIQUID. NO LEAKS. WAS ADDITIONAL MEDICAL/DRUG INTERVENTION NECESSARY? IF SO, PLEASE EXPLAIN. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131574 ↗MalfunctionJan 13, 2026Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059212 ↗MalfunctionJan 6, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973191 ↗MalfunctionNov 21, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
MalfunctionNov 13, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542249 ↗MalfunctionSep 17, 2025Leak/Splash; Leak/Splash
INJURIES OR ADVERSE EVENT: NO. PIV LEAKED OUT OF THE BACK AFTER REMOVING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077213 ↗MalfunctionSep 2, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937504 ↗MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679585 ↗MalfunctionJul 21, 2025Fluid/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: WHEN THEY ADMINISTERED THE NEEDLE INTO THE PATIENT, BLOOD FROM THE PATIENT STARTED COMING OUT OF THE GREY CAPPED PART ON THE PORT. THIS CAUSED THEM TO HAVE TO REMOVE THE NEEDLE, AND TRY AGAIN WITH A DIFFERENT ONE, AND IT ENDED UP BEING FINE ADDITIONAL INFO: THERE WERE NO SERIOUS EVENTS THAT HAPPENED FROM THIS INCIDENT, THE NEEDLE WAS SIMPLY REMOVED, AND A NEW ONE WAS USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560713 ↗MalfunctionJul 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: KNOW WE HAD LEAKAGE IN ONE FOR THE CATHETERS. NO IMPACT POSSIBLE IV REINSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473372 ↗MalfunctionJul 7, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO 'VALVE' DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN EMERGENCY ROOM NURSE AT THE CHÂTELLERAULT SITE HAS SENT US A REPORT CONCERNING THE DEFECTIVE NATURE OF A DEVICE SUPPLIED BY YOUR COMPANY. THE DEVICE IN QUESTION IS A NEXIVA® SECURE IV CATHETER WITH EXTENSION, REFERENCE (B)(4), WHICH HAS RESULTED IN AN AES. CIRCUMSTANCES OF OCCURRENCE/ DESCRIPTION OF FACTS WHEN PERFORMING A BLOOD TEST ON A NEXIVA CATHETER, THE VALVE WAS DEFECTIVE, CREATING A HEMOTOMA AT THE POINT OF FUNCTION, RESULTING IN AN AES FOR THE CAREGIVER. CLINICAL CONSEQUENCES OBSERVED: VALVE BECAME NON-FUNCTIONAL WITH SIGNIFICANT OEDEMA (B)(6) 2025 IN THE CASE OF THE INCIDENT MENTIONED ABOVE, THE PATIENT SUFFERED: LOSS OF A FUNCTIONAL VENOUS LINE DUE TO HEMATOMA + HEMORRHAGE.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22412685 ↗MalfunctionJun 12, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFROMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22197622 ↗MalfunctionMay 5, 2025Leak/Splash; Leak/Splash
MalfunctionFeb 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351625 ↗MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING BLOOD OUT OF THE BACK OF THE IV HUB CUSTOMER RESPONSE ON JAN 20, 2025 COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? BLOOD WAS LEAKING FROM AREA CIRCLED IN PICTURE. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? YES, SEE PICTURE. WHAT WAS THE IMPACT TO THE PATIENT? IV HAD TO BE REMOVED AND NEW IV PLACED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MM-YYYY? 04-01-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323187 ↗MalfunctionJan 30, 2025Fluid/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: AFTER INSERTION AND REMOVAL OF THE NEEDLE OF THE NEXIVA # 18 GA PIV CATHETER LOT #4156837 EXP 2027-05-31, BLOOD SEEPED OUT BACK STOP PORT REQUIRING REMOVAL OF PIV AND INSERTION OF NEW PIV. PLEASE INCLUDE OUR INTERMOUNTAIN CASE NUMBER (B)(4) WITH ALL EMAIL COMMUNICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277452 ↗MalfunctionJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095537 ↗MalfunctionNov 13, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STAFF BROUGHT ME THIS CONCERN TODAY WHERE BLOOD AND SALINE STARTED COMING OUT OF THE NEXIVA IV WHERE WE RETRACT THE NEEDLE. I HAVE CIRCLED THIS IN THE ATTACHED IMAGE. HAVE YOU SEEN OR HEARD THIS BEFORE. I HAVE NOT AND THIS MIGHT JUST BE A ONE-OFF, BUT THIS IS HIGH RISK FOR EXPOSURE. LET ME KNOW YOUR THOUGHTS. 29 OCT: THERE WAS NO ADVERSE EVENT OR SERIOUS INJURY. THE PATIENT WAS STABLE, AND ANY BLOOD EXPOSURE DID NOT COME INTO CONTACT WITH THE CLINICAL STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678468 ↗MalfunctionAug 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT OUR BD NEXIVA (18 AND 20 GAUGE) HAS LEAKED OUT OF THE GRAY STOPPER WHERE THE NEEDLE COMES OUT. IT POURS OUT BLOOD AND WE HAVE TO RESTART THE IV. VERBATIM: ER HAS MENTIONED A COUPLE TIMES THAT OUR BD NEXIVA (18 AND 20 GAUGE) HAS LEAKED OUT OF THE GRAY STOPPER WHERE THE NEEDLE COMES OUT. IT POURS OUT BLOOD AND WE HAVE TO RESTART THE IV. I HAVE THE EXAMPLE FROM TODAY IN A BAG WITH THE TOP PAPER THAT HAS IV INFO. DO YOU WANT THIS? FOR EXAMPLE, WHEN YOU TAKE THE NEEDLE PART OUT LIKE THE PICTURE BELOW, BLOOD IS POURING OUT OF THE STOPPER (THE PICTURE SHOWS WHITE¿.OURS IS GRAY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20079767 ↗MalfunctionJul 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THREE DIFFERENT NEXIVA CATHETERS HAVE BEEN LEAKING WHERE THE STABILIZATION PLATFORM MEETS THE TUBING, NEAR THE HUB OF THE CATHETER. ALL 18G WITHIN THE PAST WEEK, INSERTED BY A PROFICIENT ICU NURSE. ADDITIONAL OCCURRENCE REPORTED 4 JULY WITH UNKNOWN EVENT DATE 'MID JUNE'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839204 ↗MalfunctionJul 2, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19654225 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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