BD Nexiva Diffusics 383593Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903835935), received between Sep 4, 2019 and Jun 25, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Material Separation

  "MATERIAL#: 383593, BATCH#: UNKNOWN, IT WAS REPORTED BY CUSTOMER THAT PATIENT IS HERE FOLLOWING UP ON AN IV CATHETER TO THE BROKE OFF IN THE DORSUM OF HIS HAND WHEN HE WAS AT THE HOSPITAL AND THE CATHETER WAS REMOVED. COMPLAINT VIA EMAIL. BASED ON THE NOTE I REVIEWED BELOW FROM THE PATIENT YESTERDAY, IT DOESN'T APPEAR THAT THE PLAN IS TO REMOVE THE RETAINED CATHETER FRAGMENT IN THE PATIENTS HAND. COULD YOU PLEASE ASK DR. (B)(6), IF THEY DO DECIDE TO REMOVE IT, THE FRAGMENT CAN BE RETAINED AND SO WE CAN SEND IT TO THE MANUFACTURER FOR EVALUATION".

  Patient problems: Foreign Body In Patient

  MAUDE report 25621837 ↗
• MalfunctionFeb 25, 2026Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444430 ↗
• MalfunctionApr 28, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919072 ↗
• InjuryMar 7, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21549193 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412195 ↗
• MalfunctionDec 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.25 IN TUBING SEPARATED FROM THE ADAPTOR THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT BD NEXIVA DIFFUSICS 20 GA X 1.25 IN CLOSED IV CATHETER SYSTEM. THE PRE-ATTACHED EXTENSION TUBING DISLODGED FROM THE STABILIZATION PLATFORM AFTER STARTING THE IV ON THE PATIENT. THE CAREGIVER WAS ABLE TO TAMPONED THE VEIN AND REMOVE THE CATHETER ASSEMBLY WITH ONLY A FEW CC BLOOD LOSS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. BD NEXIVA DIFFUSICS 20 GA X 1.25 IN CLOSED IV CATHETER SYSTEM. THE PRE-ATTACHED EXTENSION TUBING DISLODGED FROM THE STABILIZATION PLATFORM AFTER STARTING THE IV ON THE PATIENT. THE CAREGIVER WAS ABLE TO TAMPONED THE VEIN AND REMOVE THE CATHETER ASSEMBLY WITH ONLY A FEW CC BLOOD LOSS. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THE PRE-ATTACHED EXTENSION TUBING DISLODGED FROM THE STABILIZATION PLATFORM AFTER STARTING THE IV ON THE PATIENT. CAREGIVER WAS ABLE TO TAMPONED THE VEIN AND REMOVE THE CATHETER ASSEMBLY WITH ONLY A FEW CC BLOOD LOSS. 2. CAN YOU PLEASE PROVIDE AN EXACT D

  Patient problems: Foreign Body In Patient

  MAUDE report 20869163 ↗
• MalfunctionNov 13, 2024Device Dislodged or Dislocated

  BD NEXIVA DIFFUSICS 20 GA X 1.25 IN CLOSED IV CATHETER SYSTEM. THE PRE-ATTACHED EXTENSION TUBING DISLODGED FROM THE STABILIZATION PLATFORM AFTER STARTING THE IV ON THE PATIENT. THE CAREGIVER WAS ABLE TO TAMPONED THE VEIN AND REMOVE THE CATHETER ASSEMBLY WITH ONLY A FEW CC BLOOD LOSS. MANUFACTURER RESPONSE FOR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS, BD NEXIVA DIFFUSICS (PER SITE REPORTER). WAITING FOR THEIR INVESTIGATION RESULTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20673744 ↗
• MalfunctionOct 25, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535454 ↗
• MalfunctionAug 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.25 IN IT WAS REPORTED BY CUSTOMER THAT DISCOLORATION (BROWN) ON TIP OF DIFFUSICS CATHETER. VERBATIM: DISCOLORATION (BROWN) ON TIP OF DIFFUSICS CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973182 ↗
• MalfunctionAug 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # 383593, BATCH # 4026253, 4054221. IT WAS REPORTED THAT THE BD NEXIVA DIFFUSICS 20G X 1.25 IN WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE TIP OF THE CATHETER IS BROWN IN COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933432 ↗
• MalfunctionMar 29, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.25 IN INCOMPLETE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT AFTER TROUBLESHOOTING ISSUES AS MUCH AS POSSIBLE, WE DECIDED TO TAKE A LOOK AT ONE OF THE CATHETERS, WHICH IS THE ONE IN THE VIDEO AND THE ONE I WILL BE SENDING IN FOR INVESTIGATION. WHILE HAND FLUSHING AT 5 ML/SEC (2 SECOND FLUSH), 2 OF THE 3 TEARDROP-SHAPED HOLES WERE BLOCKED AND NOT ALLOWING SALINE TO EXIT. I BELIEVE THIS LOT OF CATHETERS WAS EXPERIENCING PRESSURE LIMITS BECAUSE OF THIS. VERBATIM: SEVERAL 20G DIFFUSICS CATHETERS HAVE BEEN PRESSURING OUT AT THE END OF THE CT SCANS. THIS DEPARTMENT HAS BEEN USING 20G DIFFUSICS FOR MANY YEARS WITHOUT ISSUE. NO OTHER CHANGES TO INJECTION PUMPS, TUBING, NEEDLESS CONNECTORS, ETC. SCANNERS ARE SET TO 300 PSI AND CTAS FLOW RATES ARE SET TO 5 ML/SEC. 4-5 INSTANCES HAPPENED WITHIN A FEW DAYS, ALL WITH DIFFERENT INSERTERS. SOME STARTED IN ED, SOME STARTED IN CT BY THE RADIOLOGY TECHS. AFTER TROUBLESHOOTING ISSUES AS MUCH AS POSSIBLE, WE DECIDED TO TAKE A LOOK AT ONE OF THE CATHETERS, WHICH IS THE ONE IN THE VIDEO AND THE ONE I WILL BE SENDING IN FOR INVESTIGATION. WHIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003872 ↗
• MalfunctionDec 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 20G X 1.25 IN HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETERS HAD AN UNKNOWN SUBSTANCE ON THEM. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SALES REP XXXXX XXXXX REPORTED THAT ON PO 662A40810, MATERIAL# 383593. 4 INDIVIDUAL CATHETERS HAD AN UNKNOWN SUBSTANCE ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385637 ↗
• MalfunctionMay 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM CAUSED EXTRAVASATION IN THE PATIENT DURING THE CT EXAM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER STATES THEY RECENTLY SWITCHED TO THE NEXIVA DIFFUSICS AND OVER THE LAST MONTH HAVE HAD ABOUT 7 EXTRAVASATION. THEY ARE ABLE TO DRAW BLOOD AND FLUSH WITH OUT ISSUES. WHEN THEY POWER INJECT THE PATIENT APPEARS FINE AND NOT IN PAIN, BUT THE EVALUATION OF THE IV SITE AFTER SHOWS EXTRAVASATION. SHE IS UNCLEAR IF IT IS A PLACEMENT ISSUE OR ISSUE WITH THE CATHETER... I HONESTLY DO NOT KNOW THIS INFORMATION AS ITS CHARTED IN THE PATIENTS CHARTS AND DID NOT KEEP A LIST OF THE PATIENT'S NAMES UNTIL NOW. THE EXAMS WERE CT¿S THE EXAMS FOR THE MOST PART WERE SCANNED AS A WITHOUT CONTRAST BECAUSE THERE WAS NO CONTRAST IN THE IMAGES ON 2 OF THEM, I WOULD SAY 2 OR 3 OF THEM WERE STOPPED AND WE WERE ABLE TO START ANOTHER IV AND CONTINUE WITH THE CONTRAST THAT WAS LEFT AND ONE OF THE EXAMS WAS INJECTED THE ENTIRE AMOUNT AND THE RADIOLOGIST APPROVED US TO START A NEW IV AND INJECT IN THE OTHER ARM TO COMPLETE THE SCAN, AND 2 OR 3 WERE

  Patient problems: Extravasation

  MAUDE report 16894748 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM TIP BROKE OFF INTO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REVIEWED WITH CLINICAL TEAM AND THAT TIP HAD BROKEN OFF IN PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 16318637 ↗
• MalfunctionFeb 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM TIP WAS SHORTER THAN NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN NURSE WENT TO REMOVE IV CATHETER FROM PATIENTS ARM SHE NOTICED IT WAS SHORTER THEN NORMAL. IT WAS REMOVED AND COMPARED/MEASURED TO SIMILAR CATHETER AND IT IS SHORTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318624 ↗
• MalfunctionMay 13, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHILE USING BD NEXIVA¿ DIFFUSUS¿ CLOSED IV CATHETER SYSTEM THE NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 383593 ¿ DID NOT RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397360 ↗
• MalfunctionApr 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD NEXIVA DIFFISUS CATHETER, FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   "OPENED UP A NEW CATHETER PACKAGE AND GENTLY PULLED BACK ON THE FINGER GRIP AND NOTED A BLACK SPECK AT THE TIP OF THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121813 ↗
• MalfunctionAug 19, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT NEXIVA DIFFUSICS 20G X 1.25 IN CATHETER KINKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NURSE COULD FEEL THE CATHETER BENT AND OUTSIDE OF THE VEIN - WHEN I TOOK THE CATHETER OUT I WAS ABLE TO SEE WHERE IT WAS BENT IN HER ARM.   VERBATIM: I PLACED A 20G IV IN PT'S L AC WITH THE NEW IVS, BD NEXIVA DIFFUSICS. WHEN ORIGINALLY PLACED LINE WORKED GREAT. WHEN TAKEN TO CT LINE WOULD NOT WORK. WHEN I FELT THE PT'S ARM I COULD FEEL THE CATHETER BENT AND OUTSIDE OF THE VEIN. WHEN I TOOK THE CATHETER OUT I WAS ABLE TO SEE WHERE IT WAS BENT IN HER ARM. PT HAS BEEN IN PAIN AND MOVING FREQUENTLY. I PLACED A NEW LINE AND PT WAS ABLE TO GET HER CT. THIS IS THE THIRD TIME I HAVE HAD SOMETHING SIMILAR HAPPEN. THESE IV CATHETERS SEEM TO BE COMING OUT OF THE VEINS AND BENDING IN THE PT'S ARMS AFTER THEY HAVE BEEN MOVING AROUND. THIS HAS THE POTENTIAL TO CAUSE INFILTRATIONS IF PT'S ARE RECEIVING INFUSIONS OR DRIPS AND THEY MOVE AROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345975 ↗
• MalfunctionApr 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEXIVA DIFFUSICS 20G X 1.25 IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383593 BATCH NO.: 0267605, 0233540. IT WAS REPORTED 20G DIFFUSICS CATHETER IS LEAKING OUT THE BACK END OF THE CATHETER. IV IS STILL IN PLACE BUT PIV IS LIKELY TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675763 ↗
• MalfunctionDec 31, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEXIVA DIFFUSICS 20G X 1.25 IN LEAKED OUT OF A HOLE IN THE NEEDLE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383593 BATCH NO.: UNKNOWN. IT WAS REPORTED THERE WAS LEAKING OUT OF A SMALL HOLE IN THE BASE OF THE NEEDLE. PER MEDWATCH: AN IV WAS PLACED BY RADIOLOGIST TECHNICIAN. DURING PREFLUSH WITH 10ML SALINE, SALINE WAS NOTED TO BE LEAKING OUT OF A SMALL HOLE NEAR THE BASE OF THE NEEDLE. THIS CREATED AN ADDITIONAL STICK FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9534338 ↗
• MalfunctionSep 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEXIVA DIFFUSICS 20G X 1.25 IN CONNECTOR CAME APART FROM THE TUBING DURING USE WHILE INSERTING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE WAS INSERTING THE IV CATHETER AND ENTIRE END/CONNECTOR OF THE CATHETER CAME APART FORM THE TUBING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961612 ↗