BD Nexiva 383576Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20GA X 1.00 IN DP WITH MAXZERO · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903835768), received between Feb 8, 2022 and Sep 16, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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
- Material Protrusion/Extrusion2
- Deformation Due to Compressive Stress1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Difficult or Delayed Activation1
- Leak/Splash1
- Material Deformation1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20227223 ↗MalfunctionSep 6, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20GA X 1.00 IN DP WITH MAXZERO TUBING DEFECTIVE / DAMAGED. IT WAS REPORTED BY CUSTOMER THAT NEXIVA CATHETER EXTENSION SET "BLEW UP" DURING CT SCAN WHEN USING ISOVUE300 AND ISOVUE370. VERBATIM: NEXIVA CATHETER EXTENSION SET "BLEW UP" DURING CT SCAN WHEN USING ISOVUE300 AND ISOVUE370. ADDITIONAL INFORMATION RECEIVED ON 16AUG. HELLO, BECAUSE THE PRODUCT WAS USED ON THE PATIENT IN OUR EMERGENCY ROOM, WE DO NOT HAVE ANY PACKAGING WITH A SPECIFIC LOT NUMBER. THE PRODUCT NUMBER IS 383576. I ALSO HAVE THE ITEM IN MY POSSESSION THAT LOOKS ALMOST MELTED. THE CLINICAL STAFF WILL NEED TO ANSWER IF ANYTHING HAPPENED TO THE PATIENT. THANK YOU. ADDITIONAL INFORMATION RECEIVED ON 16AUG. NO HARM TO PATIENT. ALL HAVE BEEN INSTRUCTED TO RETAIN ANY FUTURE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163582 ↗MalfunctionJan 11, 2024
ISSUE WITH THIS DEVICE BENDING INSIDE THE PATIENT'S VEIN DURING INSERTION, ALL ITEMS REMOVED FROM THE SHELF.
Patient problems: Insufficient Information
MAUDE report 18491107 ↗MalfunctionDec 13, 2023
NEXIVA 20 GA IV, CATHETER TIPS ARE KINKING AND FOLDING INSIDE OF PATIENTS. MULTIPLE RN'S HAVE EXPERIENCED THE SAME ISSUE.
Patient problems: Failure of Implant
MAUDE report 18317811 ↗MalfunctionNov 21, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18186428 ↗MalfunctionAug 14, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD A BULGE NEAR THE EXTENSION WINGS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PROBLEM INFORMATION. CITE CUSTOMER REF#(B)(4) 20G CATHALON INITIATED TO L ACF. WHEN RETURNED FROM CT THE NEXIVA 20G HAD A BULGE IN THE EXTENSION BY THE WINGS. THE BULGE WAS RIGHT BESIDE THE WING AS IT COMES OUT TO THE EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17546995 ↗MalfunctionJun 30, 2023Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE CATHETER KINKED DURING INFUSION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN STARTED PERIPHERAL IV, FLASH NOTED, AND CATHETER THREADED WITHOUT DIFFICULTY. FLASH STOPPED AT THE END OF THE TUBING, RN ATTEMPTED TO FLUSH CATHETER AND IMMEDIATELY ENCOUNTERED RESISTANCE. PATIENT REPORTED NO PAIN AT SIDE. RN REMOVED PERIPHERAL IV CATHETER; END OF CATHETER TIP BENT SIGNIFICANTLY BUT INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17240471 ↗MalfunctionMay 11, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ DUAL PORT MAXZERO NEEDLELESS CONNECTOR THE TUBING EXPANDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CT SCAN AND CONTRAST ADMINISTRATION, IV TUBING ATTACHED TO NEXIVA HERNIATED OUT, BUT DID NOT RUPTURE. IV WAS REMOVED AND RESTARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16915984 ↗MalfunctionApr 18, 2023Device Dislodged or Dislocated
DURING CT SCAN AND CONTRAST ADMINISTRATION, IV TUBING ATTACHED TO NEXIVA HERNIATED OUT, BUT DID NOT RUPTURE. IV WAS REMOVED AND RESTARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16761080 ↗MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ DUAL PORT MAXZERO NEEDLELESS CONNECTOR A THE NEEDLE DETACHED FROM THE SAFETY MECHANISM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383576 BATCH NO.: 0300545 IT WAS REPORTED THAT NEEDLE WAS EXPOSED AND NOT PROTECTED, AFTER IV WAS STARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13638756 ↗MalfunctionFeb 8, 2022Material Protrusion/Extrusion; Protective Measures Problem
IV WAS STARTED USING 20G BD NEXIVA CLOSED IV CATHETER. AFTER IV WAS STARTED AND NEEDLE WAS DISCONNECTED FROM CATHETER, NEEDLE CAME OUT EXPOSED AND NOT PROTECTED
Patient problems: Insufficient Information
MAUDE report 13479893 ↗
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 16, 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