BD Nexiva Diffusics 383591Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00382903835911), received between May 2, 2017 and Apr 20, 2026 — classified as 5 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Integrity Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD SIMILAR CASE WITH THE SAME PRODUCT RESULTING IN BRUISING FOR THE PATIENT. VERBATIM: "GOOD MORNING, IN THIS SPECIFIC CASE, WE HAVE NO HARM. WE HAD SIMILAR CASE WITH THE SAME PRODUCT RESULTING IN BRUISING FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926528 ↗
• MalfunctionApr 16, 2026Material Integrity Problem

  IT WAS REPORTED BY CUSTOMER THAT "IV BLEW APART WHILE INJECTING SALINE FLUSH" VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED MEDICAL DEVICE PROBLEM REPORT TO VENDOR REQUEST FOR LOT/COMPLAINTS REVIEW ALBERTA MDIP # 15546 DEVICE AVAILABLE FOR INVESTIGATION: NO PLEASE SEE THE BELOW DEVICE PROBLEM REPORT. NO SERIOUS HARM WAS REPORTED. UNFORTUNATELY, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. A PRODUCTION LOT REVIEW (WHEN LOT NUMBER PROVIDED) AND A SUMMARY REPORT OF COMPLAINTS, PROBLEMS AND INCIDENTS (INCLUDING LEVEL OF HARM) ASSOCIATED WITH THIS DEVICE IS REQUESTED, TO BE PROVIDED WITHIN NINETY (90) DAYS. NEXT STEPS ¿ YOUR ACTIONS PLEASE REFERENCE THE ALBERTA MDIP (INDICATED ABOVE) IN ALL COMMUNICATION ASSOCIATED WITH THIS MDIP AND COPY ME IN ALL COMMUNICATION. PROVIDE YOUR FILE/REFERENCE NUMBER FOR THIS MDIP REPORT. PLEASE SEND ME THE FINAL REPORT AND COPY THE PRIMARY CLINICAL CONTACT AND MANAGER (SEE NAMES BELOW), AS WELL AS (B)(6). PROVIDE REPLACEMENT OR CREDIT DETAILS AS APPROPRIATE AND ADVISE ONCE CREDIT OR REPLACEMENT HAS BEEN COMPLETED. PLEASE DO NOT REACH OUT WITH AUTOMATED, REDUNDANT OR UNNECESSARY QUESTIONS ABOUT THE PROBLEM, EVENT OR DEVICE. SHOULD YOU REQUIRE INFORMAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904050 ↗
• MalfunctionApr 15, 2026Material Integrity Problem

  IT WAS REPORTED BY THE CUSTOMER THAT IV CATHETER WOULD NOT THREAD, WHEN CLINICIAN REMOVED WHOLE IV AND NEEDLE, THE NEEDLE WAS POKED THROUGH THE CATHETER ITSELF. VERBATIM: IV CATHETER WOULD NOT THREAD, WHEN CLINICIAN REMOVED WHOLE IV AND NEEDLE, THE NEEDLE WAS POKED THROUGH THE CATHETER ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887947 ↗
• MalfunctionFeb 19, 2026Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390096 ↗
• MalfunctionFeb 19, 2026Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390088 ↗
• MalfunctionFeb 3, 2026Material Integrity Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD MULTIPLE CATHETERS HAVE THE NEEDLE SPLIT THROUGH THE PLASTIC CATHETER. VERBATIM: MY ED HAS REPORTED AN ISSUE WITH THE BD 22GA NEXIVA DIFFUSICS CATHETER. THEY HAD MULTIPLE CATHETERS HAVE THE NEEDLE SPLIT THROUGH THE PLASTIC CATHETER. BELOW IS THE PACKAGING OF THE LOT# WE HAD ISSUES WITH SLITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248527 ↗
• MalfunctionSep 4, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN - 383591 - FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BROWN-LIKE RESIDUE LOCATED ON THE TIP OF THESE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964862 ↗
• MalfunctionAug 27, 2025Crack; Crack

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN - (B)(6) - TUBING DEFECTIVE / DAMAGED. ON INSERTION THE RN NOTED THE TUBING, IN THE EXTENSION, SECTION HAD A CRACK AND WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904268 ↗
• MalfunctionAug 26, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896826 ↗
• InjuryAug 1, 2025Break; Break

  CUSTOMER RESPONSE ON 06-AUG-2025. YES, IN ATTEMPTS TO REMOVE THE BROKEN PIECE OF CATHEETER, MULTIPLE DIAGNOSTIC EXAMINATIONS WERE COMPLETED TO VISUALIZE AND PHYSICIAN INTERVENTION TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693117 ↗
• MalfunctionJul 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN CATHETER DEFECTIVE / DAMAGED MATERIAL#: 383591, LOT#: 5038592. IT WAS REPORTED BY CUSTOMER THAT THE TUBE SECTION OF THE IV DETACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO, ITEM: 383591, QUANTITY AFFECTED: 1 EACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636152 ↗
• MalfunctionJul 1, 2025Material Perforation; Material Perforation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373276 ↗
• MalfunctionJul 1, 2025Material Perforation; Material Perforation

  NO ADDITIONAL INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373268 ↗
• MalfunctionJun 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT THE CATHETER WAS LEAKING FROM. THE IV CATHETER WAS PLACED AND FLUSHED. ONCE THE IV BEGAN TO INFUSE IT WAS REALIZED THAT FLUID WAS LEAKING FROM THE TUBING EXTENSION AT THE Y-SITE (ARROW INDICATES LEAKING AREA). VERBATIM: I ATTACHED A PICTURE BELOW. I THOUGHT THIS WOULD BE THE EASIEST WAY TO EXPLAIN WHERE THE CATHETER WAS LEAKING FROM. THE IV CATHETER WAS PLACED AND FLUSHED. ONCE THE IV BEGAN TO INFUSE IT WAS REALIZED THAT FLUID WAS LEAKING FROM THE TUBING EXTENSION AT THE Y-SITE (ARROW INDICATES LEAKING AREA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284662 ↗
• MalfunctionJun 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN NEEDLE THROUGH CATHETER IT WAS REPORTED BY CUSTOMER THAT PENETRATED THE SKIN AND THE PLASTIC CATHETER SHEATH WAS PROGRESSING ABOVE THE SKIN WHILE THE NEEDLE WAS STILL IN THE TISSUE. SO THE NEEDLE HAD GONE THROUGH BUT MAYBE THE CATHETER HAD A TEAR OR WAS PUNCTURED ALREADY. WE KEPT THE PRODUCT AND CONTAINER. VERBATIM: I WAS AT THE BEDSIDE WITH THE NURSE WHEN SHE WAS USING THIS SPECIFIC CATHETER THAT HAD THE ISSUE. SHE HAD PENETRATED THE SKIN AND THE PLASTIC CATHETER SHEATH WAS PROGRESSING ABOVE THE SKIN WHILE THE NEEDLE WAS STILL IN THE TISSUE. SO THE NEEDLE HAD GONE THROUGH BUT MAYBE THE CATHETER HAD A TEAR OR WAS PUNCTURED ALREADY. WE KEPT THE PRODUCT AND CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163817 ↗
• MalfunctionMay 16, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS HUB WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: 2025-04-30 LEVEL OF HARM: NO APPARENT HARM. INCIDENT DETAILS: PATIENT WAS RECEIVING CHEMOTHERAPY STARTED. USING A DIFFUSICS CLOSED IV CATHETER SYSTEM 22G 1.00IN. PATIENT WENT TO THE BATHROOM AND WHEN SHE EXITED THE BATHROOM, SHE NOTICED THAT BLOOD WAS BACKING UP IN THE IV LINE AND IT WAS LEAKING BLOOD FROM THE CONNECTION SITE. IV LINE CLAMPED AND SPILL CONTAINED. LINE TIGHTENED WITH NO RELIEF OF THE LEAK. IT WAS DISCOVERED THAT THE DIFFUSIC CONNECTOR WAS CRACKED LENGTHWAYS DOWN THE LIGHT BLUE END. IV HAD TO BE DISCONTINUED AND RESTARTED. TREATMENT COMPLETED WITHOUT FURTHER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039218 ↗
• MalfunctionApr 30, 2025Leak/Splash; Leak/Splash

  NO ADDITION INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934527 ↗
• MalfunctionApr 24, 2025Material Puncture/Hole; Defective Component; Material Puncture/Hole; Defective Component

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN CATHETER WAS DEFECTIVE / DAMAGED. IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO START A 22GA (1.00 IN) IV ON A PATIENT IN THE ER, FELT THE CATHETER WAS IN THE VEIN, BUT GOT MINIMAL FLASH, ONLY IN THE TUBE AND DID NOT FILL THE CHAMBER. AFTER PATIENT DISCHARGED ANOTHER NURSE AND PRIMARY NURSE EXAMINED CATHETER AND DISCOVERED THAT THERE APPEARED TO BE HOLES IN THE END OF THE CATHETER THAT A SALINE FLUSH CAME OUT OF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. REFENCE 383591 ITEM DESCRIPTION CATHETER IV 22GA X1 CT ING QAUNTITY (B)(4) EA LOT 4184064 EXP UNKNOWN EVENT DISCRIPTION WHILE ATTEMPTING TO START A 22GA (1.00 IN) IV ON A PATIENT IN THE ER, FELT THE CATHETER WAS IN THE VEIN, BUT GOT MINIMAL FLASH, ONLY IN THE TUBE AND DID NOT FILL THE CHAMBER. ATTEMPTED TO ADVANCE NEEDLE FURTHER INTO THE VEIN WITH NO MORE SUCCESS GETTING BLOOD. WITHDREW THE NEEDLE AND ATTEMPTED TO MANIPULATE THE CATHETER IN AND OUT TO GET MORE BLOOD RETURN TO CONFIRM PLACEMENT IN THE VEIN. NO MORE BLOOD RETURN SEEN. ATTEMPTED TO PULL CATHETER OUT WITH SOME RESISTANCE. MOVED CATHETER AROUND SOME MORE AND ABLE TO GET CATHETER OUT WITH CATHETER TIP ATTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901410 ↗
• MalfunctionApr 2, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753382 ↗
• MalfunctionMar 25, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687836 ↗
• MalfunctionMar 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN HAD A CRACK. IT WAS REPORTED BY CUSTOMER THAT THEY WENT TO FLUSH IT AND TOWARDS THE END OF THE SALINE FLUSH IT STARTED LEAKING. SHE FOUND A CRACK ON THE SAME LITTLE PIECE. VERBATIM: FROM CUSTOMER- ¿SEVERAL MONTHS AGO I HAD A PATIENT'S IV LEAK DUE TO PART OF THE IV BEING CRACKED. WHEN WE HOOKED UP THE POWER INJECTOR TO THE IV AND UNCLAMPED IT, IT LEAKED AND POURED BLOOD ALL OVER THE PATIENT AND THE FLOOR BECAUSE IT WAS CRACKED AND THERE WAS NO LONGER A SEAL. WE THOUGHT IT WAS SOMETHING TOTALLY RANDOM AND MOVED ON. BUT ANOTHER TECH TOLD ME THAT 2 WEEKS AGO THE SAME EXACT THING HAPPENED AT ONE OF OUR OTHER OFFICES, HE STARTED AN IV, HOOKED UP SALINE AND IT STARTED LEAKING BECAUSE THERE WAS A CRACK ON THE PIECE WE CONNECT CONTRAST/SALINE TO. AND THEN TODAY THE SAME THING HAPPENED TO OUR TECH ASSISTANT. SHE STARTED AN IV, WENT TO FLUSH IT AND TOWARDS THE END OF THE SALINE FLUSH IT STARTED LEAKING. SHE FOUND A CRACK ON THE SAME LITTLE PIECE. SHE HAD TO RESTART THE PATIENT¿S IV BECAUSE THERE'S JUST NO WAY AROUND THAT CRACK.¿ THE ONE THAT HAPPENED TODAY. WE HAVE THE LOT NUMBER 4247514. I DON¿T KNOW IF THIS HAS BEEN REPORTED BY ANYONE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687829 ↗
• MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21565227 ↗
• MalfunctionFeb 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BD NEXIVA DIFFUSUS 22G X 1.00 IN CATHETER BROKE / SEPARATED AFTER PLACEMENT. IT WAS REPORTED BY THE CUSTOMER THAT IV CATHETER TUBING IS SEPARATED FROM THE HUB IN THE PACKAGING MAKING THE DEVICE UNUSABLE AND UNSAFE. THIS HAS BEEN DISCOVERED ON TWO IV CATHETERS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IV CATHETER TUBING IS SEPARATED FROM THE HUB IN THE PACKAGING MAKING THE DEVICE UNUSABLE AND UNSAFE. THIS HAS BEEN DISCOVERED ON TWO IV CATHETERS.

  Patient problems: Insufficient Information

  MAUDE report 21293472 ↗
• MalfunctionJan 31, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1 CATHETER TIP INTEGRITY IT WAS REPORTED BY CUSTOMER THAT THEY HAD DIFFICULTY WITH INSERTION, UNABLE TO FLUSH, NO BLOOD ASPIRATED, AND STATED LARGE CLOT ON CATHETER TIP. NEW NEXIVA DIFFUSICS INSERTED (HOSPITAL NURSE TRAINING ANOTHER NURSE ON NEW PRODUCT), HAD DIFFICULTY WITH INSERTION, UNABLE TO FLUSH, NO BLOOD ASPIRATED, REMOVED IV AND STATED LARGE CLOT ON CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286736 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN CATHETER WAS DEFECTIVE / DAMAGED IT WAS REPORTED BY CUSTOMER THAT, WHILE GAUGE IV INSERTED INTO VEIN. UNABLE TO ADVANCE BECAUSE CATHETER HAD A HOLE IN IT.++ BLEEDING AT SITE, UNABLE TO ADVANCE, IV PULLED. VERBATIM: PROBLEM INFORMATION COMPLAINT (B)(4) GAUGE IV INSERTED INTO VEIN. UNABLE TO ADVANCE BECAUSE CATHETER HAD A HOLE IN IT.++ BLEEDING AT SITE, UNABLE TO ADVANCE, IV PULLED. OCCURRENCES: 1 EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151954 ↗