BD Nexiva 383510Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903835102), received between Mar 22, 2019 and Sep 4, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 9/16 IN SINGLE PORT - CATHETER DEFECTIVE / DAMAGED. IT WAS REPORTED BY CUSTOMER THAT CATHETER STRAW KINKED AND SLIGHTLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962383 ↗
• MalfunctionSep 2, 2025Break; Material Separation; Break; Material Separation

  COMPLAINT CATEGORY: DAMAGED / BROKEN INCIDENT DATE: 28 JUL 2025 DETAILS OF COMPLAINT (REPORTED ISSUE): ¿WRITER WENT TO ASSESS PIV; PIV APPEARED TO BE FLUSHING WELL. ON ASSESSMENT, WRITER NOTICED THAT FLUSH VOLUME HAD ABSORBED INTO PIV ARM BOARD AS PIV ARM BOARD WAS MOIST. ON ASSESSMENT, THE PIV CATHETER TUBING WAS NOTED TO BE SNAPPED IN HALF.¿ COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947895 ↗
• MalfunctionMay 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER CUSTOMER "ITEM IS NOT WORKING, TRYING TO DRAW BLOOD, BLOOD NOT GOING THROUGH THE LINE, WHEN REMOVED FROM THE PART BLOODS ARE COMING OUT." (B)(6). 1. COULD YOU PLEASE CONFIRM IF THE STATEMENT 'BLOODS ARE COMING OUT' REFERS TO LEAKAGE FROM THE DEVICE? THE CUSTOMER SAID WHEN THE NURSE PUT THE NEEDLE IN THE BLOOD WOULD NOT FLOW THROUGH THE LINE AND WHEN THEY REMOVED THE NEEDLE FROM THE ARM BLOOD WAS DRIPPING LIKE IT WAS STUCK BUT WOULDN'T FLOW THROUGH THE LINE. 2. IF THERE IS A LEAKAGE, COULD YOU SPECIFY WHERE THE LEAKAGE IS COMING FROM? WHEN THEY PULL OUT THE NEEDLE. WAS THERE AN INJURY: NO. WAS THERE A DEATH: NO. (B)(6) 2025. COULD YOU PLEASE CONFIRM IF THE RETURNED BATCHES WERE AFFECTED? YES. ARE THESE BATCHES ASSOCIATED WITH DIFFERENT COMPLAINTS? NO. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084833 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034848 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034846 ↗
• MalfunctionMay 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DETAILS: AS PER CUSTOMER "ITEM IS NOT WORKING, TRYING TO DRAW BLOOD, BLOOD NOT GOING THROUGH THE LINE, WHEN REMOVED FROM THE PART BLOODS ARE COMING OUT." (B)(6). 1. COULD YOU PLEASE CONFIRM IF THE STATEMENT 'BLOODS ARE COMING OUT' REFERS TO LEAKAGE FROM THE DEVICE? THE CUSTOMER SAID WHEN THE NURSE PUT THE NEEDLE IN THE BLOOD WOULD NOT FLOW THROUGH THE LINE AND WHEN THEY REMOVED THE NEEDLE FROM THE ARM BLOOD WAS DRIPPING LIKE IT WAS STUCK BUT WOULDN'T FLOW THROUGH THE LINE. 2. IF THERE IS A LEAKAGE, COULD YOU SPECIFY WHERE THE LEAKAGE IS COMING FROM? WHEN THEY PULL OUT THE NEEDLE. WAS THERE AN INJURY: NO. WAS THERE A DEATH: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999497 ↗
• MalfunctionNov 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEXIVA CATHETER IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE COMPLAINTS FROM RNS REGARDING 24 GAUGE BD NEXIVA PIV CATHETERS BEING DULL OR HAVING A PLASTIC SHEATH OVER THEM. RNS REALIZE THIS WHEN GOING TO INSERT PIV FOR PATIENTS AND UNABLE TO PIERCE SKIN WITH PIV.

  Patient problems: Insufficient Information

  MAUDE report 18119134 ↗
• MalfunctionJun 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEXIVA¿ SINGLE PORT CATHETER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS BLEEDING AND IV WAS LEAKING OUT SO HAD TO BE REMOVED."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17083657 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.56 IN THE TUBING RUPTURED DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383510, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE LINE BROKE BETWEEN THE YELLOW LUERLOCK AND THE IV CATHETER WHILE INSITU. DATE OF INCIDENT: NOT PROVIDED AT TIME OF ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515557 ↗
• MalfunctionOct 29, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD NEXIVA¿ SINGLE PORT CATHETER WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "IT IS IMPOSSIBLE TO PURGE THEM BEFORE PRICKING THE VEIN AND FOR OTHERS, IT IS IMPOSSIBLE TO PIERCE THE SKIN TO MOUNT THE CATHETER IN THE VEIN. PATIENT PRICKED SEVERAL TIMES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759727 ↗
• MalfunctionJan 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I HAVE A 24 GAUGE NEXIVA IV CATHETER THAT WAS USED ON A PATIENT THAT HAD A LEAK BETWEEN THE HUB AND TUBING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9597284 ↗
• InjuryNov 26, 2019Mechanical Jam

  MATERIAL NO. 383510, BATCH NO. 9227579. IT WAS REPORTED THAT DURING USE OF THE NEXIVA 24 GA X 9/16 IN SINGLE PORT ONE OF THE NURSES WAS STUCK BY THE NEEDLE WHEN TRYING TO EXTRACT THE EXPOSED NEEDLE FROM THE NEXIVA PORT WHICH WAS STUCK IN THE IV PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INJURY RESULTED WHEN THE NURSE WAS TRYING TO REMOVE THE MALE END OF THE VACUTAINER HOLDER FROM THE NEXIVA FEMALE PORT. THE LUER SLIP END TYPICALLY GETS STUCK IN THIS PORT, AND THE VACUTAINER HOLDER LUERS OFF, LEAVING THE INTERNAL NEEDLE FULLY EXPOSED TO THE NURSE. TWO NURSES THEN TRIED TO EXTRACT THE EXPOSED NEEDLE FROM THIS NEXIVA PORT, WHICH WAS CONTAMINATED WITH PATIENT BLOOD, AND ONE OF THE NURSES WAS STUCK BY THE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9378026 ↗
• MalfunctionOct 28, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD NEXIVA¿ SINGLE PORT CATHETER WAS NOTICED TO BE SPLIT FROM THE NEEDLE HUB TO THE TIP DURING USE WHILE ADVANCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON ADVANCING THE CATHETER NOTICED IT WAS SPLIT FROM THE HUB OF THE NEEDLE TO THE TIP PERFECTLY. REMOVED THE NEEDLE AND CATHETER WAS INTACT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244870 ↗
• MalfunctionMar 28, 2019Leak/Splash

  IT WAS REPORTED THAT A BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM) HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "MATERIAL NO: 383510 BATCH NO: UNKNOWN . IT WAS REPORTED THAT CATHETER IS SHREDDING DURING PLACEMENT. CUSTOMER ALSO INDICATED IN FOLLOW UP EMAIL THAT THE CATHETER LEAKED AT THE JUNCTION OF THE J-LOOP AND BLUE PORT. ", WE ARE HAVING AN ISSUE WITH THE BD NEXIVA IV CATH SHREDDING DURING PLACEMENT. I AM UNCERTAIN OF ALL THE DETAIL, SO I WANTED TO REACH OUT TO YOU AND GET YOU CONNECTED WITH THE APPROPRIATE PEOPLE. , CAN YOU PROVIDE MORE DETAILS. THANK YOU, FOLLOW UP EMAIL FROM CUSTOMER RECEIVED ON 12/14/2018 STATES, "WITH THIS INSTANCE FROM THE OTHER DAY (I AM GETTING MY DAYS CONFUSED RIGHT NOW), WE WENT INTO THE PATIENT ROOM AFTER THE MOM CALLED OUT AND SAID SHE THOUGHT THE PATIENT HAD PULLED HIS IV OUT. WHEN WE WENT INTO THE ROOM, THE WRAPPING AND BEDDING WERE COVERED IN BLOOD. WE UNWRAPPED THE IV AND WHEN WE GOT TO THE SITE IT HAD NOT BEEN PULLED OUT AND WAS STILL IN PLACE. I GOT A FLUSH TO SEE IF I COULD FIGURE OUT WHERE THE BLOOD WAS COMING FROM AND WHEN I FLUSHED IT, WATER AND BLOOD CAME SQUIRTING OUT OF THE JUNCTION WHERE THE CONNECTED J-LOOP MEETS WITH THE END PORT

  Patient problems: Blood Loss

  MAUDE report 8460943 ↗
• MalfunctionMar 22, 2019Break; Leak/Splash

  IT WAS REPORTED THAT A BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM) HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "MATERIAL NO: 383510. BATCH NO: UNKNOWN . IT WAS REPORTED THAT CATHETER APPEARED TO HAVE PARTIALLY BROKE AND THE SITE STARTED BLEEDING. PER CUSTOMER EMAIL: WE DID HAVE ANOTHER ISSUE YESTERDAY (B)(6)18). WE WERE TRYING TO START AN IV ON A 15MON PT ADMITTED WITH RESP DISTRESS, DEHYDRATION, AND FEVER (ROOM 470). ON THE FIRST STICK, I STUCK HER LEFT HAND. I GOT IMMEDIATE FLASH AND BLEED BACK AND AS I WENT TO ADVANCE THE CATHETER, THE CATHETER APPEARED TO HAVE PARTIALLY BROKE AS I WAS WITHDRAWING THE NEEDLE AS THE SITE STARTED BLEEDING BETWEEN THE YELLOW WINGS AND THE ACTUAL INSERTION SITE. WE IMMEDIATELY REMOVED THE CATHETER AND ENSURED THE TIP WAS INTACT. THE CATHETER WE SAVED AND IS IN A BIOHAZARD BAG LABELED WITH THE PATIENTS STICKER AND WE GAVE IT TO DAY SHIFT TO GIVE YOU."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444710 ↗