BD Nexiva Diffusics 383590Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS 24G X 0.75 IN · Class 2
All models of BD Nexiva Diffusics (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva Diffusics is a short-term IV catheter used to draw blood and give fluids. The 62 reports mostly describe the catheter leaking or splashing, blood or fluid leaking from it, and the material cracking, breaking or puncturing — including needles pushing through the catheter wall, ends coming off, and catheters that would not flush. One report involved an injury and no deaths were reported. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00382903835904), received between Feb 19, 2018 and Apr 7, 2026 — classified as 1 injury, 60 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (22 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
- Leak/Splash22
- Fluid/Blood Leak9
- Break6
- Material Integrity Problem6
- Material Puncture/Hole5
- Air/Gas in Device3
- Crack3
- Defective Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blood Loss1
- Infiltration into Tissue1
- Menstrual Irregularities1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Fluid/Blood Leak; Material Integrity Problem
IT WAS REPORTED BY CUSTOMER THAT HARD TO GET BLOOD TO DRAW FROM THESE; IT WOULD NOT EVEN FLUSH AFTER THE IV WAS REMOVED; HOLE ON SIDE OF CATHETER NOTED. VERBATIM: I HAVE BEEN GETTING A FEW REPORTS THAT WE ARE HAVING ISSUES WITH THE NEXIVA DIFFUSICS CATHETERS, PARTICULARLY WHEN TRYING TO FLUSH THE CATHETERS. INITIALLY THE COMPLAINT WAS ""THESE ARE HARD TO GET BLOOD TO DRAW FROM THESE. BUT LAST NIGHT A COUPLE OF PEOPLE CAME TO TALK TO ME ABOUT THIS ISSUE AS WELL. AND THINKING ABOUT IT, THE MAIN ONES I HAVE BEEN CALLED FOR ARE THE 24 GA DIFFUSICS, I CAN GET THEM TO DRAW MOST OF THE TIME BUT IT TAKES A WHOLE LOT OF WORK, SOMETIMES I CANNOT GET THEM TO DRAW AT ALL THOUGH."" MOST RECENTLY AS OF LAST NIGHT I HAD THIS COMPLAINT, ""TONIGHT AN IV WAS IN AND WHEN THE RN TRIED TO FLUSH IT SHE WAS UNABLE, IT WOULD NOT EVEN FLUSH AFTER THE IV WAS REMOVED."" HERE IS SOME ADDITIONAL INFORMATION THAT WAS PROVIDED,"" WHILE ATTEMPTING TO OBTAIN IV DURING AN ED IV CREW CALL, UV OBTAINED TO LEFT WRIST. IMMEDIATE BLOOD RETURN. WHEN ATTEMPTING TO FLUSH EXTREME DIFFICULTY, FLUSHING IV AND UNABLE TO FLUSH. WHEN CATHETER WAS REMOVED FROM PATIENT STILL DIFFICULTY FLUSHING. WHEN EVENTUALLY ABLE TO GET THE FLU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809385 ↗MalfunctionMar 30, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716825 ↗MalfunctionMar 25, 2026Material Integrity Problem
IT WAS REPORTED BY CUSTOMER THAT WHEN WRITER WENT TO FLUSH AND USE IV, THE END OF DIFFUSICS IV HAD FALLEN OFF. VERBATIM: EVENT DATE: (B)(6) 2026 - IV DIFFUSICS 24G PLACED IN PATIENT PREVIOUS TO MY SHIFT ON (B)(6). IV HAD PREVIOUSLY BEEN WORKING AND HAD BOLUS COMPLETED. WHEN WRITER WENT TO FLUSH AND USE IV, THE END OF DIFFUSICS IV HAD FALLEN OFF. IV REMOVED AND MANAGER AS WELL AS MD MADE AWARE. AT THIS TIME NO KNOWN HARM TO THE PATIENT. HAVE USED SAMPLE TO PROVIDE FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688947 ↗MalfunctionFeb 19, 2026Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390095 ↗MalfunctionFeb 19, 2026Material Integrity Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE 24 GAUGE NEXIVA DIFFUSICS IV CATHETER NEEDLE PIERCED THROUGH THE CATHETER WHEN THE NURSE WAS ATTEMPTING TO ADVANCE THE CATHETER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. "WE HAVE TWO IV CATHETERS IN MALFUNCTION. THE 24 GAUGE NEXIVA DIFFUSICS IV CATHETER NEEDLE PIERCED THROUGH THE CATHETER WHEN THE NURSE WAS ATTEMPTING TO ADVANCE THE CATHETER. THE OTHER CATHETER HAS DONE THE SAME THING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390084 ↗MalfunctionFeb 9, 2026Leak/Splash; Material Integrity Problem; Air/Gas in Device
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24294702 ↗MalfunctionNov 19, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594360 ↗MalfunctionNov 19, 2025Air/Gas in Device; Air/Gas in Device
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594357 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511855 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23511854 ↗MalfunctionAug 22, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN-FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT A MOISTURE BUBBLE WAS FOUND INSIDE THE NEEDLE PROTECTIVE HOUSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22875941 ↗MalfunctionAug 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN- NEEDLE RETRACTION FAILURE. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS RESISTANCE WHEN ATTEMPTING TO RETRACT THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874198 ↗MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT "BLOOD WAS POURING OUT OF THE CATHETER WHERE THE LINE MEETS THE HARD PLASTIC HUB". VERBATIM: BLOOD WAS POURING OUT OF THE CATHETER WHERE THE LINE MEETS THE HARD PLASTIC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841911 ↗MalfunctionAug 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN NEEDLE THROUGH CATHETER IT WAS REPORTED BY CUSTOMER THAT THE CATHETER IS EXTREMELY FLIMSY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "FACTUAL DESCRIPTION OF THE EVENT: BD NEXIVA DIFFUSICS 24 GA IV CATHETER, THE STYLETTE PIERCED THROUGH THE CATHETER DURING INSERTION. THE CATHETER IS EXTREMELY FLIMSY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742339 ↗MalfunctionJun 5, 2025Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN CATHETER DEFECTIVE / DAMAGED AND LEAKED IT WAS REPORTED BY CUSTOMER THAT HOLE IN CATHETER, LEAKING IN MIDDLE OF PLASTIC CATHRON? SPLINT RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION PRODUCT CODE: 383590 PRODUCT DESCRIPTION: CATHETER IV CLOSED NEXIVA DIFFUSICS 24G X 0.75IN BX/20 LOT/SERIAL #: (B)(6) EXPIRY DATE: PENDING PROBLEM INFORMATION :NOTE CUSTOMER COMPLAINT # (B)(4) HOLE IN CATHETER, LEAKING IN MIDDLE OF PLASTIC CATHRON ? SPLINT OCCURRENCES: 1 EACH REPORTER INFORMATION REPORTER NAME: XXXXX REPORTER POSITION/DEPARTMENT: REPORTER REPORTER PHONE: XXXX REPORTER EMAIL: XXXXXXXX SITE INFORMATION XXX XXXXXX XXXXXXX XXXXXXX SAMPLE INFORMATION INCIDENT SAMPLES: PENDING REPRESENTATIVE SAMPLES: 1 BOX
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22151591 ↗MalfunctionMay 21, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PIV INSERTED INTO HAND, AS COLLEGUE WAS RETRACTING NEEDLE, NEEDLE WENT THROUGH CATHLON. IV NEEDING TO BE REMOVED. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062796 ↗MalfunctionMay 15, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027454 ↗MalfunctionApr 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN LEAKED. IT WAS REPORTED BY CUSTOMER THAT LEAKING RCC RECEIVED A COMPLAINT VIA EMAIL. HI CUSTOMER SERVICE, HOPE ALL IS WELL. WE WOULD LIKE TO REPORT A PRODUCT DEFECT/COMPLAINT. PLEASE PROCESS CREDIT OR AN RMA FOR THIS PRODUCT FOR YOUR INVESTIGATION. KINDLY REFERENCE CUSTOMER¿S# AND CARDINAL CIF ON ALL EMAILS AND CORRESPONDENCE. CUSTOMER REFERENCE: CASE: (B)(4), CARDINAL PO: (B)(4), ITEM: 383590, CUSTOMER PO: (B)(4), LOT#: 345882, CASE INTAKE FORM SUBMITTED THRU CARDINAL: CASE: (B)(4), INITIAL REPORTER: DESCRIPTION AS REPORTED: "LEAKING" SAMPLE LOCATION: FOR QUESTIONS ABOUT THE SAMPLE, HERE¿S THE CONTACT DETAILS OF THE CUSTOMER. CUSTOMER NAME: CUSTOMER PHONE NUMBER: CUSTOMER EMAIL ADDRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884015 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT NOTED TO NOT HAVE FILTER ON THE END AND CAUSED BLEEDING FROM THE END OF THE TUBING AS NO TYPICAL NEED TO HOLD PRESSURE OR CLAMP TUBING. INCIDENT OR PROBLEM INFORMATION. REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON - INCONVENIENT. INCIDENT DETAILS: NEXIVA DIFFUSICS WAS NOTED TO NOT HAVE FILTER ON THE END AND CAUSED BLEEDING FROM THE END OF THE TUBING AS NO TYPICAL NEED TO HOLD PRESSURE OR CLAMP TUBING. NOTED RIGHT AWAY, RESOLVED, NO EXTREME BLOOD LOSS, IV OTHERWISE FUNCTIONING WELL. NO FILTER NOTED IN THE PACKAGING. PROCEDURE: IV INSERTION. DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM YELLOW 24GAX19MM NEXIVA DIFFUSICS. MANUFACTURER CODE/MODEL: 383590. SERIAL OR LOT NUMBER: (B)(6). DEVICE EXPIRY DATE (YYYY-MM-DD): 2025-03-12. SUPPLIER CATALOGUE NUMBER: 333-383590. WAS THE DEVICE RETAINED? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766716 ↗MalfunctionJan 15, 2025Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN CATHETER BROKE / SEPARATED AFTER PLACEMENT AND LEAKED IT WAS REPORTED BY CUSTOMER THAT THE IV WAS PLACED ON PATIENT AND NEEDLE RETRACTED. AS NEEDLE RETRACTED, BLOOD BEGAN TO POOL UNDER CATHETER. CATHETER LEAKING AND DISCONNECTED FROM CONNECTION POINT. VERBATIM: HI, I RECEIVED SAFETY REPORT 428207 FROM . WAS THE NURSE WHO FILED THE REPORT. BD NEXIVA DIFFUSICS 24GA X 0.75 IN LOT # 4095520, EXP 03/31/2027. IV WAS PLACED ON PATIENT AND NEEDLE RETRACTED. AS NEEDLE RETRACTED, BLOOD BEGAN TO POOL UNDER CATHETER. CATHETER LEAKING AND DISCONNECTED FROM CONNECTION POINT. CATHETER REMOVED FROM PATIENTS ARM FULLY INTACT. NO HARM TO PATIENT. ALL PIVS ASSOCIATED WITH THIS LOT# WERE REMOVED FROM INFUSION ROOM AND STOCK SUPPLIES. WANTED TO BRING THIS TO YOUR ATTENTION. LET ME KNOW IF YOU NEED ANY FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159366 ↗MalfunctionNov 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN LEAKED. IT WAS REPORTED BY CUSTOMER THAT 2 MORE DEFECTIVE NEXIVAS TO RETURN. WHEN WENT TO POWER INJECT AT A RATE OF 2/SEC IV INFILTRATED. ON THE SECOND ONE WHEN WENT TO HAND INJECT IV INFILTRATION. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE 2 MORE DEFECTIVE NEXIVAS TO RETURN. BOTH OF THEM ARE REF: 383590, BOTH ARE LOT: 4176473. WHAT WAS THE IMPACT TO THE PATIENT? INFILTRATED. PATIENT WILL NEED TO RETURN CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 10/31/2024 AND 11/1/2024. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? REF: 383590, LOT: 4176473. SAMPLE AVAILABLE IS MENTIONED AS YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? XX. CUSTOMER RESPONSE: 1. PLEASE PROVIDE THE ISSUE IN DETAIL. WHEN WENT TO POWER INJECT AT A RATE OF 2/SEC IV INFILTRATED. ON THE SECOND ONE WHEN WENT TO HAND INJECT IV INFILTRATION. 2. PLEASE DESCRIBE THE TERM "DEFECT NEXIVAS". WHAT TYPE OF DEFECT IS THAT? DO NOT KNOW EXACT ¿DEFECT¿ BUT ALL OF A SUDDEN, WE ARE GETTING INFILTRATES WITH TECHNOLOGIST THAT HAVEN¿T HAVE INFILTRATES IN 20 YEARS. ¿SOMETHING IS AMISS.¿ 3. PLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781962 ↗MalfunctionNov 26, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781432 ↗MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 24G X 0.75 IN LEAKED AT LUER CONNECTION. IT WAS REPORTED BY CUSTOMER THAT THE BLOOD LEAKAGE OBSERVED NEAR THE LUER LOCK (WHERE THEY CONNECT THE EXTENSION OR NEEDLE FREE CONNECTOR) AT THE INSERTION. VERBATIM: BLOOD LEAKAGE OBSERVED NEAR THE LUER LOCK (WHERE THEY CONNECT THE EXTENSION OR NEEDLE FREE CONNECTOR) AT THE INSERTION. HE WANTS TO KNOW IF WE HEARD ABOUT OTHER CASES LIKE THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726035 ↗MalfunctionNov 8, 2024Crack; Crack
ADDITIONAL INFORMATION RECEIVED ON 22OCT LOT UNKNOWN AS PACKAGING NOT KEPT. PATIENT REQUIRED A SECOND POKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20637917 ↗MalfunctionNov 8, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20637522 ↗
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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.
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