BD Nexiva, BD Q-Syte 383532Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 22GA 1.00IN Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva IV catheter is a short-term catheter used for intravenous access. Many of the 289 reports describe fluid or blood leaking, sometimes from a loose cap, and some describe parts breaking or poorly sealed packaging. Reports rose from 28 in the prior 12 months to 44 in the last 12 months. The reports include no deaths and 12 injuries. 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
- 282
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 00382903835324), received between Oct 13, 2017 and Jul 2, 2026 — classified as 11 injuries, 271 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (96 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash96
- Fluid/Blood Leak25
- Break23
- Device Contamination with Chemical or Other Material18
- Device Markings/Labelling Problem16
- Difficult or Delayed Activation16
- Retraction Problem12
- Material Protrusion/Extrusion11
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- No Known Impact Or Consequence To Patient67
- No Consequences Or Impact To Patient21
- Insufficient Information16
- Hypersensitivity/Allergic reaction5
- Hemorrhage/Blood Loss/Bleeding4
- Device Embedded In Tissue or Plaque3
- Swelling3
Recent adverse event reports
The 25 most recent of 282 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA COMPONENT LEAKED. THE DOCTOR HAD RAISED AN ISSUE THAT THE LEAKAGE IS OBSERVED FROM THE Q SYTE ON NEXIVA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692796 ↗MalfunctionJun 30, 2026Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA ADAPTER SPLIT. DETAILED INCIDENT DESCRIPTION: WHEN A NURSE WAS ON HER WAY TO MEDICATE THE PATIENT, SHE NOTICED THAT THE QSYTE WAS SPLIT INTO TWO. THE OUTER PART OF THE CAP, WHERE THE SILICONE SEPTUM IS LOCATED, HAD NEATLY DETACHED FROM THE CANNULA, WHILE THE THREADED PORTION ATTACHED TO THE CANNULA REMAINED IN PLACE. THE CANNULA CLAMP WAS CLOSED SO THE SYSTEM REMAINED CLOSED; HOWEVER, A NEW CANNULA HAD TO BE INSERTED BEFORE MEDICATION COULD BE ADMINISTRATED. ADDITIONAL INFORMATION (E.G., PROCEDURE, DURATION OF PROCEDURE, WHETHER THE PROCEDURE COULD BE COMPLETED): THE PATIENT WAS TAKEN TO THE DOCTOR, WHERE IT WAS NOTICED THAT THE Q-PULSE VALVE WAS BROKEN. THE NEXIVA "CLIP" WAS INTACT, SO NO BLOOD CAME OUT OF THE CANNULA. THE CANNULA WAS REMOVED AND DISCARDED. A NEW CANNULA WAS INSERTED AND THE PATIENT WAS TREATED. RESPONSE RECEIVED ON: 6/24/2026 THE PATIENT HAD TO BE RECANNULATED, SO BASICALLY YES, THE PATIENT WAS HARMED. THE LOT-NUMBER WAS NOT PROVIDED SINCE IT WAS NOT WRITTEN DOWN AT THE TIME OF THE EVENT. NOT POSSIBLE TO HAVE IT AFTERWARDS. THE ISSUE IS ABOUT A NEXIVA DUAL PORT, WHERE THE QSYTE WAS INCLUDED IN THE PACKAGE. THIS QSYTE WAS THE ONE THA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664524 ↗MalfunctionJun 25, 2026Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT BD NEXIVA LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626466 ↗MalfunctionJun 8, 2026
PRODUCT OKAY TO USE BUT THE DUAL PORT CAP IS LOOSE NOW AND BLOOD BACKS UP AND OUT OF LINE. NEVER DONE THAT BEFORE. CATCHES NURSE AND PATIENT OFF GUARD. THE DUAL PORT, 1 TO FLUSH LINE AND THE 2ND USED TO BE SECURE BUT IT ISN'T ANY MORE. IS THIS IN ERROR? THIS HAS HAPPENED ON SEVERAL OCCASIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25426115 ↗MalfunctionJun 5, 2026Material Split, Cut or Torn
MICRO TEAR OBSERVED ON THE CATHETER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410410 ↗MalfunctionJun 1, 2026Leak/Splash; Loose or Intermittent Connection
DURING USE: CUSTOMER REPORTING ACROSS ALL AREAS OF THE HOSPITAL THAT WHEN FLUSHING OR GIVING MEDS THE ATTACHED HUB IS LOOSE AND LEADS TO SPRAY OF FLUSH/MEDICATIONS BEING GIVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353042 ↗MalfunctionJun 1, 2026Leak/Splash; Loose or Intermittent Connection
DURING USE: CUSTOMER REPORTING ACROSS ALL AREAS OF THE HOSPITAL THAT WHEN FLUSHING OR GIVING MEDS THE ATTACHED HUB IS LOOSE AND LEADS TO SPRAY OF FLUSH/MEDICATIONS BEING GIVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353041 ↗MalfunctionJun 1, 2026Material Integrity Problem
WE'VE RECEIVED A REPORT FROM XXX OF 1 PIECE OF 383532 NEXIVA 22GA WITH BATCH NUMBER 5071138. INSERTED INTRAVENOUS ACCESS ON THE LEFT ANTECUBITAL VEIN OF THE PATIENT AND STARTED TO NOTICE BLOOD LEAKAGE FROM THE DISTAL CATHETER LINE. REMOVED THE IV CATHETER AND APPLIED PRESSURE ON THE IV SITE. ICE COMPRESS PROVIDED. INFORMED PATIENT REGARDING THE SITUATION. UPON CHECKING, THE IV CATHETER APPEARS TO HAVE A MICRO-TEAR ON THE CATHETER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348724 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
PRIOR TO IV INSERTION, CHARGE NURSE ASSESSED THE IV CATHETER, AND IT APPEARS TO BE FUNCTIONAL. INSERTED IV CATHETER ON THE LEFT ANTECUBITAL VEIN OF THE PATIENT AND STARTED TO NOTICE BLOOD LEAKAGE FROM THE DISTAL CATHETER LINE. REMOVED THE IV AND APPLIED PRESSURE ON THE IV SITE. ICE COMPRESS PROVIDED. INFORMED PATIENT REGARDING THE SITUATION. RE-INSERT IV LINE. UPON CHECKING, IV CATHETER APPEARS TO HAVE A MICRO-TEAR ON THE CATHETER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219741 ↗MalfunctionMay 18, 2026Delivered as Unsterile Product; Packaging Problem
THE CUSTOMER REPORTED PACKAGE DAMAGE WITH STERILITY BREECH. MANY BD NEXIVA PACKAGES BEING OPENED AND LOSING THEIR STERILITY. SOME PACKAGES REMAINED INTACT; HOWEVER, THE SHAPE OF THE IV CATHETER PACKAGING WAS ALREADY COMPROMISED. THE HOSPITAL IS RELUCTANT TO USE THE PRODUCTS DUE TO CONCERNS REGARDING PRODUCT SAFETY AND QUALITY THE PLASTIC PART OF THE PACKAGING APPEARED SHRIVELED, AS IF EXPOSED TO EXTREME HEAT, RESULTING IN MANY BD NEXIVA PACKAGES BEING OPENED AND LOSING THEIR STERILITY. SOME PACKAGES REMAINED INTACT; HOWEVER, THE SHAPE OF THE IV CATHETER PACKAGING WAS ALREADY COMPROMISED. THE HOSPITAL IS RELUCTANT TO USE THE PRODUCTS DUE TO CONCERNS REGARDING PRODUCT SAFETY AND QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200880 ↗MalfunctionApr 21, 2026Break; Activation, Positioning or Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944371 ↗MalfunctionApr 15, 2026Leak/Splash
IT WAS REPORTED THAT THERE WAS A LEAKAGE AT THE SEPTUM. AFTER PLACING DRIP, BLOOD CAME DRIPPING OUT OF THIS (SEE ARROW) CAP, SOMETHING THAT SHOULD NOT BE POSSIBLE. THIS ALSO HAPPENED TO ONLY ONE DRIP FROM THIS LOT NUMBER. HAS THIS PRODUCT ALREADY BEEN USED IN PATIENTS: YES. HAS THERE BEEN ANY RISK TO THE PATIENT OR USER: NO. RESPONSE RECEIVED ON: 4/10/2026 WHAT DIFFERENCE DOES IT MAKE EXACTLY WHEN THE INCIDENT OCCURRED? IN ANY CASE, IT WAS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887949 ↗MalfunctionApr 11, 2026Material Integrity Problem
THE PROCEDURE IS PERFORMED CORRECTLY DURING INSERTION AND PERFORATION OF THE SKIN. WHEN BLOOD RETURN IS OBSERVED IN THE CATHETER, THE NEEDLE IS WITHDRAWN SLIGHTLY, THE ANGLE IS ADJUSTED, AND THE CATHETER IS ADVANCED FURTHER INTO THE VEIN, AFTER WHICH THE NEEDLE IS REMOVED. SUBSEQUENTLY, IN ALL CASES, THE CATHETER HAS NOT BEEN FUNCTIONAL. UPON REMOVAL OF THE PIVC, IT WAS NOTED THAT THE PLASTIC CATHETER HAD FRACTURED AND WAS ONLY HELD TOGETHER BY A VERY SMALL AMOUNT OF PLASTIC. ONE MIGHT SUSPECT THAT THE NEEDLE PERFORATED THE CATHETER, BUT WE NEVER ADVANCE THE NEEDLE AGAIN AFTER IT HAS BEEN WITHDRAWN SLIGHTLY, SO THIS SHOULD NOT BE THE CAUSE. WE THEREFORE WONDER HOW THIS COULD OCCUR RESPONSE RECEIVED ON:(B)(6) 2026 COULD YOU PLEASE CONFIRM THE PATIENT IMPACT? IT DID NOT HAVE ANY IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851809 ↗MalfunctionApr 2, 2026Fluid/Blood Leak; Material Separation
MalfunctionMar 24, 2026Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677174 ↗MalfunctionMar 16, 2026Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605951 ↗MalfunctionMar 12, 2026Fluid/Blood Leak; Leak/Splash
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581659 ↗MalfunctionMar 9, 2026Break
WE HAVE HAD REPORT OF BROKEN NEEDLES WITH THESE 22G IV SYSTEMS.
Patient problems: Insufficient Information
MAUDE report 24547668 ↗MalfunctionMar 9, 2026Leak/Splash
WE HAVE HAD REPORT OF LEAKING WITH THESE 22G IV SYSTEMS.
Patient problems: Insufficient Information
MAUDE report 24547656 ↗MalfunctionMar 2, 2026Leak/Splash
MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT BROKEN NEEDLES OCCURRED WITH 22G IV SYSTEMS.
Patient problems: Insufficient Information
MAUDE report 24490038 ↗MalfunctionFeb 10, 2026Crack; Leak/Splash
NEXVIA CRACKED AT ONE OF THE INJECTION PORTS AND FLUID AND BLOOD CAME FROM THE CRACK IN THE INJECTION SITE THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.
Patient problems: Insufficient Information
MAUDE report 24305437 ↗InjuryFeb 3, 2026Break; Material Separation
IT WAS REPORTED THAT THE CATHETER BROKE OR SEPARATED. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT10-30-2025. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WENT TO FLUSH 22G IV IN PATIENT'S LEFT FOREARM AND IT IMMEDIATELY SPRAYED SALINE OUT OF IV SITE; UPON INSPECTION, IT WAS NOTED THAT CANNULA WAS BROKEN OFF AT THE HUB OF IV. PALPATION NOTED NO REAL FIRM AREA SURROUNDING SITE. ANESTHESIA THEN USED ULTRASOUND AT SITE TO TRY AND LOCATE CANNULA.
Patient problems: Foreign Body In Patient
MAUDE report 24247809 ↗MalfunctionJan 30, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223862 ↗MalfunctionJan 30, 2026Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221397 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page