BD Nexiva Diffusics 383594Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903835942), received between Sep 18, 2020 and Feb 4, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 18G X 1.25 IN CATHETER IS DEFECTIVE / DAMAGED. IT WAS REPORTED BY CUSTOMER THAT THEY ARE NOT ABLE TO USE DIFFUSICS 18G CATHETERS FOR CARDIAC SCANS AT 6ML/SEC AT 325PSI BECAUSE THEY ARE IMMEDIATELY PRESSURING OUT. TEXAS HEALTH FRISCO CT DEPARTMENT IS NOT ABLE TO USE DIFFUSICS 18G CATHETERS FOR CARDIAC SCANS AT 6ML/SEC AT 325PSI BECAUSE THEY ARE IMMEDIATELY PRESSURING OUT. THE LOT NUMBER IS #2290249. WE DID A VARIETY OF TESTS INCLUDING POWER INJECTING CONTRAST OVER A TRASH CAN WITH DIFFUSICS WITH A COMPETITOR NFC, DIFFUSICS WITH NO NFC, DIFFUSICS WITH MAX, DIFFUSICS XL WITH MAX, DIFFUSICS XL WITH NO NFC, AS WELL AS A 20G DIFFUSICS. THEIR POWER INJECTOR WAS RECENTLY CALIBRATED AND THEIR CONTRAST TUBING IS RATED FOR 400PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303998 ↗
• MalfunctionMay 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CUSTOMER RESPONSE ON APRIL 23, 2024. LOT NUMBERS AS FOLLOWS: 3076931, 3236215, 3306528, 3270882, 3077239, 3214181, 3270878, 3298351, 3270891, 3270886.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287816 ↗
• MalfunctionJan 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 18G X 1.25 IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT VENT CAP ON DIFFUSICS HAD A HOLE IN IT VERBATIM: VENT CAP ON DIFFUSICS HAD A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476948 ↗
• MalfunctionDec 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 3 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER NEEDLE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OMITTED STATED THAT THE NURSES OPENED THREE PACKAGES IN A ROW THAT ALL HAD THE SAME PROBLEM OF YELLOWISH RUSTED TIPS. THE LOT NUMBER IS 0203331. OMITTED ORDERS THIS PRODUCT FROM OMITTED AND THE ITEM HAS BEEN ON BACK ORDER AND THE PRODUCT THAT WAS RECEIVED HAS THIS YELLOWISH RUSTED TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997230 ↗
• MalfunctionSep 20, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED WHILE USING BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN THE SAFETY MECHANISM DIDN'T WORK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I SAFETY THE NEEDLE, IT POPPED OUT THE END OF THE GREY HOUSING EXPOSING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452625 ↗
• MalfunctionFeb 3, 2022Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN CATHETER WAS FOUND TO BE DEFORMED AND BULGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: 1082458   IT WAS REPORTED BY THE CONSUMER THE IVS ARE BILGING AT THE TIP OF THE CATHETER, YELLOW AND MALFORMED.   VERBATIM: LOT 1082458 OF 18 GAUGE DIFFUSICS IVS ARE BULGED OUT WHERE THE SIDE PORTS ARE LOCATED AT THE TIP OF THE CATHETER. THIS AREA IS ALSO YELLOW AND MALFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441907 ↗
• MalfunctionDec 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM HAD A CATHETER TIP THAT WAS DEFORMED AND DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIFFUSICS AREA OF FENESTRATED TIP IS ENLARGED/DISCOLORED."

  Patient problems: Pain

  MAUDE report 13052493 ↗
• MalfunctionDec 8, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM HAD A HOLE IN THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED HOLES ON THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964812 ↗
• MalfunctionNov 23, 2021Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER HAD "YELLOW TINTING" AND DEFECTIVE CATHETER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW TINTING AND BULGING ON TIP OF CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864781 ↗
• MalfunctionNov 9, 2021Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM WAS DAMAGED AND DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THERE WAS A YELLOW TINT AND BULGING AT THE FENESTRATION OF THE CATHETERS.   VERBATIM: YELLOW TINT AND BULGING AT THE FENESTRATION OF THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776493 ↗
• MalfunctionNov 4, 2021Material Perforation; Material Perforation

  IT WAS REPORTED WHEN USING THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM, THE DEVICE EXPERIENCED THE NEEDLE PERFORATING THROUGH THE CATHETER. THIS EVENT OCCURRED FOUR TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CATHETER HAS IS DAMAGE BY THE POINT OF THE NEEDLE WHERE IT IS INTRODUCE TO THE BODY CUSTOMER SAID IT HAD HAPPENED 4 TIMES AND HE HAS ONE OF THE PRODUCT TO RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755289 ↗
• InjuryApr 23, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM THE HUB. AN ULTRASOUND WAS PERFORMED ON THE PATIENT WHERE A BROKEN PORTION OF THE NEEDLE/CANNULA WAS FOUND EMBEDDED WITHIN THE PATIENT. THE INCIDENT REQUIRED A DOCTOR TO PERFORM A "SKIN NICK" TO REMOVE THE BROKEN CANNULA/NEEDLE PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383594 BATCH NO: 0294778 AN 18G NEXIVA DIFFUSICS WAS PLACED IN THE RIGHT AC ON A 49 YO WOMAN FOR AN OUTPATIENT CTA. IV WAS INSERTED WITH EASE, NO RECANNULATION. SCAN WAS PERFORMED AT 6ML/325 PSI WITH NO ISSUES. WHILE THE NURSE WAS REMOVING THE IV (POST-SCAN) SHE FELT A "POP" WHILE TRYING TO REMOVE THE CATHETER. WHEN THE CATHETER CAME OUT, SHE FELT LIKE PART OF IT WAS MISSING. SHE USED AN ULTRASOUND TO SCAN THE ARM AND COULD SEE THE REMAINING APROX 1CM OF CATHETER IN THE SUB Q TISSUE. THE PORTION OF THE CATHETER WITH FENESTRATIONS WAS IN THE TISSUE. A DOCTOR PERFORMED A SKIN NICK TO REMOVE IT. BOTH PIECES WERE KEPT AND ARE AVAILABLE TO SEND BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713408 ↗
• MalfunctionApr 19, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEXIVA DIFFUSICS 18G X 1.25 IN HAD FOREIGN MATTER AND THE CATHETER TIP WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383594 BATCH NO: 0329097 AND 0294778. IT WAS REPORTED BROWN COLORING AROUND HOLES ON DIFFUSICS CATHETER, TIP OF CATHETER WAS BRITTLE AND BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691076 ↗
• MalfunctionSep 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 40 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383594 BATCH NO.: 0052947. THE USER FACILITY OPENED MATERIAL 383594 AND SAW WHAT THEY DESCRIBE AS " YELLOW DEBRIS NEAR THE GREEN BUTTERFLY WHERE THE TUBE IS". NURSE SAW THIS WHEN SHE OPENED THE PACKAGING. THEY HAVE PULLED THE LOT AND ARE SEQUESTERING IT AS A PRECAUTION.

  Patient problems: No Patient Involvement

  MAUDE report 10557287 ↗