BD Nexiva, BD Q-Syte 383536Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20GA 1.00IN HF Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Nexiva IV catheter has 375 reports, with no deaths and 9 injuries. Most describe malfunctions, mainly fluid leaking at the connections, parts coming apart, and breaks. There are 2 recalls: a 2021 one, still open, over packaging breaches that can leave the product non-sterile, and a 2019 one, now closed, over a leak that can burst under high pressure and expose health workers to blood. Recent reports rose from 25 to 37 compared with the period before.
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
- 374
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 00382903835362), received between Oct 20, 2017 and Sep 29, 2026 — classified as 9 injuries, 365 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (140 reports).
2 FDA recall records name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 8, 2021Class IIOpen, Classified
There is a breach in the product packaging that renders the product non-sterile.
Z-0306-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 1, 2019Class IITerminated
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Z-1710-2019 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash140
- Material Separation31
- Fluid/Blood Leak30
- Break23
- Detachment of Device or Device Component20
- Difficult or Delayed Activation19
- Retraction Problem18
- Device Contamination with Chemical or Other Material15
Patient problems
- No Known Impact Or Consequence To Patient159
- No Clinical Signs, Symptoms or Conditions155
- No Consequences Or Impact To Patient18
- Insufficient Information12
- Blood Loss6
- No Information6
- No Patient Involvement5
- Pain5
Recent adverse event reports
The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936988 ↗MalfunctionSep 15, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780231 ↗MalfunctionSep 15, 2026Crack; Fluid/Blood Leak
No new information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780224 ↗MalfunctionSep 2, 2026Fluid/Blood Leak; Material Deformation; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567715 ↗MalfunctionJun 26, 2026Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE ADAPTER/TUBING JUNCTION. "WHEN PLACING IV 20 GAUGE, BLOOD BACK FLOWED AS NORMAL BUT LEAKED OUT THE TUBING WHERE THE PINK ADAPTER CONNECTS." NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636230 ↗MalfunctionJun 25, 2026Improper Flow or Infusion
IT WAS REPORTED THAT BD NEXIVA LEAKED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026. WHEN YOU STATE THAT ¿WHEN THE CONTRAST WAS INJECTED ON ONE SIDE, IT CAME OUT THE OTHER,¿ IS THE CONTRAST COMING OUT OF THE SECTION WHERE THE NEEDLE IS REMOVED FROM THE WINGED CONNECTOR, FROM THE SECOND END OF THE DUAL-PORT ADAPTER AT THE TIP OF THE EXTENSION TUBE, OR FROM SOME OTHER PART OF THE DEVICE? ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 IN RESPONSE TO YOUR REQUEST, WE WOULD LIKE TO INFORM YOU THAT THERE WAS NO HARM TO THE PATIENTS INVOLVED IN THE EVENTS REPORTED. DURING THE EVENTS, IT WAS ONLY OBSERVED THAT THE PATIENTS WERE WETTED BY THE CONTRAST RESULTING FROM THE LEAK IDENTIFIED. THERE WERE NO INJURIES, CLINICAL COMPLICATIONS OR NEED FOR ADDITIONAL MEDICAL INTERVENTION. AS AN IMMEDIATE CORRECTIVE MEASURE, THE CONTRAST WAS ONLY REAPPLIED SO THAT THE EXAMS COULD BE COMPLETED PROPERLY, WITHOUT ANY FURTHER IMPACT ON THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627869 ↗MalfunctionJun 4, 2026Leak/Splash
IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. ADDITIONAL INFORMATION RECEIVED ON 15 MAY 2026: WAS THERE ANY HARM TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. NO DID THE SPILLED LIQUID COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROFESSIONAL¿S SKIN OR MUCOSA? IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. BECAUSE THE MATERIAL WAS CONTAMINATED, IT COULD NOT BE STORED. WE SEPARATED THE ENTIRE BATCH IN QUESTION WAS THE PROFESSIONAL WEARING PPE? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399872 ↗MalfunctionJun 4, 2026Leak/Splash
IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. ADDITIONAL INFORMATION RECEIVED ON 15 MAY 2026: WAS THERE ANY HARM TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. NO DID THE SPILLED LIQUID COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROFESSIONAL¿S SKIN OR MUCOSA? IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. BECAUSE THE MATERIAL WAS CONTAMINATED, IT COULD NOT BE STORED. WE SEPARATED THE ENTIRE BATCH IN QUESTION WAS THE PROFESSIONAL WEARING PPE? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399869 ↗MalfunctionJun 2, 2026Improper Flow or Infusion
IT WAS REPORTED THAT WHEN INJECTING CONTRAST IN ONE WAY, IT WAS COMING OUT IN THE OTHER. NOT REACHING THE PATIENT AND WETTING THE PATIENT AND STRETCHER. THE SITUATION WAS OBSERVED FOR 3 DIFFERENT EPISODES. WHAT IS THE DATE OF THE INCIDENT? 12-01-2026.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25366665 ↗MalfunctionMay 28, 2026Leak/Splash; Material Integrity Problem
A RN WAS COMPLETING AN IV INSERTION ON A PATIENT FOR A CT SCAN. NURSE NOTICED BLOOD COMING FROM THE IV CATHETER TUBING. THERE WAS A HOLE IN THE TUBING WHERE THE TUBING IS CONNECTED TO THE NEEDLE PORTION. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321902 ↗MalfunctionMay 15, 2026Leak/Splash; Material Deformation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186923 ↗MalfunctionMay 14, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE NEXIVA IV TUBING WAS KINKED. IV PLACED IN PATIENT, UNABLE TO FLUSH, KINKED OFF DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PATIENT HAD TO BE RE-POKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178194 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE OCCURRED. WHEN UNCLAMPING TO FLUSH, BLOOD BACKFLOWS AND LEAKS OUT UNDER THE CAP. CAP CHANGED, LEAKING CONTINUED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PATIENT HAD TO BE RE-POKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177763 ↗MalfunctionMay 12, 2026Leak/Splash; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154231 ↗MalfunctionApr 28, 2026Material Separation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016654 ↗MalfunctionApr 23, 2026Crack; Leak/Splash
IT WAS REPORTED THAT THE HUB WAS CRACKED. "HE STARTED THE IV, REMOVED THE FILTER AND ATTACHED THE SYRINGE TO DRAW BLOOD. THERE WAS A CRACK IN THE PINK PLASTIC THAT LEAKED BLOOD AND AIR ALL OVER." PATIENT HARM/OUTCOME: "UNSURE".
Patient problems: Insufficient Information
MAUDE report 24965772 ↗MalfunctionApr 23, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB WAS CRACKED. "HE STARTED THE IV, REMOVED THE FILTER AND ATTACHED THE SYRINGE TO DRAW BLOOD. THERE WAS A CRACK IN THE PINK PLASTIC THAT LEAKED BLOOD AND AIR ALL OVER." PATIENT HARM/OUTCOME: "UNSURE".
Patient problems: Insufficient Information
MAUDE report 24965401 ↗MalfunctionApr 22, 2026Crack
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958379 ↗MalfunctionApr 21, 2026Leak/Splash; Nonstandard Device
IT WAS REPORTED THAT THE LEAKAGE OCCURRED. "IV START WORKED FINE, ONCE RN WENT TO FLUSH IV, IV HUB STARTED LEAKING DESPITE HUBS BEING TIGHTENED. IV HAD TO BE EXCHANGED FOR NEW ONE. AFTER IV REMOVED AND FURTHER INVESTIGATED, IV APPEARED TO HAVE BEEN INDENTED". "NEEDED A NEW IV".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944372 ↗MalfunctionApr 20, 2026Leak/Splash; Material Separation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24930486 ↗MalfunctionApr 17, 2026Crack; Fluid/Blood Leak
ADDITIONAL INFORMATION 4/17/2026 NO HARM TO PATIENT. DELAY WAS PROBABLY A COUPLE OF MINUTES AS THEY HAD TO STOP TREATING THE PATIENT, GET A NEW PRODUCT, AND START OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915771 ↗MalfunctionApr 14, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876761 ↗MalfunctionMar 17, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618826 ↗MalfunctionMar 16, 2026Material Deformation
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24611624 ↗MalfunctionMar 16, 2026Leak/Splash
ADDITIONAL INFORMATION AS MENTIONED ¿TOTAL 23 QTY,¿ COULD YOU PLEASE CLARIFY WHETHER THIS REFERS TO 23 SAMPLES AVAILABLE FOR TESTING OR 23 FAULTY DEVICES THAT WERE IDENTIFIED? RESPONSE RECEIVED ON 23-MAR-2026: THE 23 TOTAL ARE THE SAME LOTS THAT WE WERE HAVING ISSUES WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607253 ↗
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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 · each recall links to the FDA recall notice
- 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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