BD Nexiva 383520Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18 GA X 1.75 IN HF SINGLE PORT · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903835201), received between May 7, 2018 and Oct 23, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
- Fluid/Blood Leak2
- Device Markings/Labelling Problem1
- Disconnection1
- Free or Unrestricted Flow1
- Separation Failure1
- Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient4
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364473 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
LEAKY SEPTUM. DURING USE. CUSTOMER: I RECEIVED A (ONE-TIME) REPORT FROM THE EMERGENCY ROOM TODAY AND ALSO SAW IT MYSELF. NEXIVA NEW ENTRY: A SMALL AMOUNT OF FLUID FROM THE RINSING SYRINGE WITH SOME BLOOD CAME OUT OF THE SEPTUM OF THE CANNULA, WHICH WAS SUPPOSED TO BE CLOSED. THE SITE WAS SIMPLY NOT TIGHT AFTER THE CANNULA WAS REMOVED. NO PATIENT WAS IMPACTED, AS THE NEXIVA WAS REPLACED. THE ISSUE OCCURRED DURING FLUSHING OF THE CATHETER WITH NACL ¿ THE FLUSH FLUID LEAKED FROM THE "BLIND SEPTUM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22919757 ↗MalfunctionNov 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA HF SINGLE PORT LEAKS AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA LEAKING FROM SEPTUM WHERE THE NEEDLE COMES OUT. IT HAS HAPPENED 4 TIMES SO FAR. (B)(6) COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? BLOOD WAS LEAKING OUT OF THE GREY SEPTUM WHERE THE NEEDLE COMES OUT TO SAFETY. THIS HAPPENED 4 DIFFERENT TIMES WITH DIFFERENT SIZE GAGE AND LENGTH CATHETERS. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. WHAT WAS THE IMPACT TO THE PATIENT? HAD TO GET A NEW LINE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO AVAILABLE SAMPLE. WHAT WAS THE FLUID AT USE? N/A, BLOOD LEAKING UPON PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20649045 ↗MalfunctionNov 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20649008 ↗MalfunctionNov 9, 2023Disconnection; Disconnection
IT WAS REPORTED THAT BD NEXIVA TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION AT THE IV EXTENSION TUBING AND THE END CAP CAME DISCONNECTED WHERE THE TUBING AND THE CAP MEET.
Patient problems: Insufficient Information
MAUDE report 18107539 ↗MalfunctionApr 14, 2023Separation Failure; Separation Failure
IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD NEXIVA¿ SINGLE PORT CATHETER WOULD NOT DISENGAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A 18 G NEXIVA FAIL TO RELEASE WHILE IN A PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16747949 ↗MalfunctionMar 20, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION POINT OF THE BD NEXIVA¿ SINGLE PORT CATHETER FLEXURE TUBE WHILE ADMINISTERING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DURING THE ADMINISTRATION OF FOREIGN BLOOD (EC), LEAKAGE OCCURRED AT THE CONNECTION POINT OF THE FLEXURE TUBE. THE BLOOD PRODUCT WAS CONNECTED TO THE CONNECTION PORT. THE BLOOD HAS LEAKED AT THE POINT WHERE THE CONNECTION PORT ENDS IN THE "WINGS" OF THE FLEXURE TUBE. THE FLEXURE PATCH WAS FOUND TO BE NEW AND UNCONTAMINATED. THE PLASTER WAS ALSO CONTAMINATED WITH BLOOD AT THE SAME RATE AS THE BLOOD WAS DRIPPING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13831203 ↗MalfunctionSep 17, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH A BD NEXIVA SINGLE PORT 18GA 1.75IN (1.3 MM X 45 MM). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PRODUCT LABELS WERE NOT ATTACHED ON 2 BOXES OF PCN 383520. ON THE OUTER CASE (1 CA X 80) THE LABEL WAS ATTACHED, BUT ON THE TWO BOXES (2 BX X 20) INSIDE THERE WERE NO LABELS ATTACHED, AND ON THE OTHER TWO BOXES LABELS WERE ATTACHED." 2 OCCURRENCES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9079213 ↗MalfunctionAug 13, 2019Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow
IT WAS REPORTED THAT AFTER NEEDLE IS REMOVED BLOOD LEAKS AT THE SEPTUM AND AIR BUBBLES ARE OCCURRING WITH A BD NEXIVA¿ 18 GA X 1.75 IN HF SINGLE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WE ARE STILL SATISFIED WITH THE NEXIVA, BUT THERE HAVE NOW BEEN 2X INCIDENTS AT THE NEXIVA PLANTS. AFTER THE NEEDLE HAS BEEN REMOVED, BLOOD RUNS THROUGH THE GRAY SEPTUM. ALSO, WHEN PURGING THE PVK, THE RINSE LIQUID WILL RUN ACROSS THE GRAY SEPTUM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8888996 ↗MalfunctionAug 8, 2019Leak/Splash; Leak/Splash
IT HAS BEEN REPORTED THAT THE BD NEXIVA SINGLE PORT 18GA 1.75IN (1.3 MM X 45 MM) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AFTER TAKING THE NEEDLE OUT, THE ACCESS WAS LEAKING AND BLOOD CAME OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8873987 ↗MalfunctionMay 7, 2018Sticking
IT WAS REPORTED THAT THERE WAS A DIFFICULT HUB DISENGAGEMENT WHEN USING A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SINGLE PORT. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7492246 ↗
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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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