BD Nexiva 383558Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903835584), received between Mar 27, 2019 and Apr 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954263 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  I WILL NEED TO MAKE A PRODUCT COMPLAINT AND RETURN A DEVICE TO YOU ALL. 20G 1.75¿ NEXIVA LOT #4276212 WAS INSERTED INTO A PATIENT. BLOOD WAS FOUND OUTSIDE OF THE CATHETER ON THE SKIN. THE IV WAS FLUSHED AND IT WAS DETERMINED THAT THE SALINE WAS LEAKING FROM A PINPOINT HOLE IN THE EXTENSION PORTION OF THE CATHETER. IV REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832436 ↗
• MalfunctionDec 4, 2024Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847661 ↗
• MalfunctionMay 6, 2024Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250382 ↗
• MalfunctionMay 5, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT WITH MAXZERO EXPERIENCED NEEDLE DISENGAGEMENT DIFFICULTY. THIS IS 2 OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PAST WEEKEND, WE HAD ANOTHER IV, SAME LOT NUMBER, DO THE SAME THING AS DESCRIBED BELOW. THEY COULDN'T GET THE NEEDLE INSIDE THE NEXIVA CATHETER OUT AFTER PLACING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882174 ↗
• MalfunctionMay 3, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT WITH MAXZERO EXPERIENCED NEEDLE DISENGAGEMENT DIFFICULTY. THIS IS 1 OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PAST WEEKEND, WE HAD ANOTHER IV, SAME LOT NUMBER, DO THE SAME THING AS DESCRIBED BELOW. THEY COULDN'T GET THE NEEDLE INSIDE THE NEXIVA CATHETER OUT AFTER PLACING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864772 ↗
• MalfunctionFeb 15, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR EXPERIENCED DIFFICULTY WITH THE NEEDLE DISENGAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY COULDN'T GET THE NEEDLE INSIDE THE NEXIVA CATHETER OUT AFTER PLACING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383847 ↗
• MalfunctionOct 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR EXPERIENCED EXPANDED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD ISSUES WITH NEXIVA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544209 ↗
• MalfunctionMar 2, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE TUBING CLAMP WAS MISSING ON THE BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER NEXIVA WAS PLACED, THE NURSE NOTICED THE PINCH CLAMP WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654223 ↗
• MalfunctionJun 1, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEXIVA 20 GA X 1.75IN SP WITH MAXZERO SAFETY MECHANISM WAS DIFFICULT TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE PLASTIC ON THE HUB WAS MISSHAPEN WHICH MADE THE NEEDLE DIFFICULT TO REMOVE FROM THE DEVICE. PER EMAIL: WHILE PLACING A BD NEXIVA 20 GAUGE 1.75" IV I WAS UNABLE TO REMOVE THE NEEDLE. PRIOR TO STARTING THE IV I "BROKE THE SEAL" ON THE IV WHICH IS THE STANDARD PRACTICE. ONCE THE IV WAS PLACED IN THE PATIENT I PULLED BACK ON THE NEEDLE AND HEARD AN AUDIBLE CLICK WHEN THE NEEDLE RETRACTED INTO ITS SAFETY NODE. AT THIS POINT, THE NEEDLE NORMALLY JUST FALLS OFF AND IS EASY TO REMOVE SAFELY. INSTEAD, THE NEEDLE REMAINED STUCK ON THE END OF THE BUTTERFLY SECTION OF THE IV. FINALLY, AFTER GENTLE AND CAREFUL MANIPULATION I WAS ABLE TO REMOVE THE NEEDLE SAFELY. UPON INSPECTION I NOTED THAT THE IV CATHETER AREA WHERE THE NEEDLE ATTACHES TO THE CATHETER HAD A SMALL DEFECT IN THE PLASTIC (THE PLASTIC WAS MISSHAPEN). THIS DEFECT I ASSUME WAS WHAT WAS HINDERING THE REMOVAL OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917456 ↗
• MalfunctionMar 27, 2019Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHILE OPENING UP A 1.75IN BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR, A 1.25IN WAS INSIDE THE PACKAGING INSTEAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GOOD AFTERNOON. TODAY IT WAS REPORTED TO ME THAT A CUSTOMER WENT TO OPEN A 20G 1.75IN NEXIVA AND INSIDE THE PACKAGING WAS A 1.25IN NEXIVA. THE PACKAGED PRODUCT REF # IS 383558. THE SAMPLE IS AVAILABLE AND WAS NOT USED. CAN YOU PLEASE SEND SHIPPING MATERIAL TO ME SO THAT I MAY SEND IT IN TO BE EXAMINED?"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8456016 ↗