BD Nexiva 383517Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20 GA X 1-1/4 IN SINGLE PORT · Class 2
Quick summary
This BD Nexiva IV catheter is an intravenous catheter for short-term use. Many of the 225 reports describe leaks, including blood leaking from the port and hubs cracking, with some describing difficult activation. The reports include 6 injuries and no deaths. 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
- 223
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00382903835171), received between Dec 1, 2017 and Jun 16, 2026 — classified as 6 injuries, 217 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (67 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash67
- Fluid/Blood Leak25
- Difficult or Delayed Activation22
- Defective Component16
- Break11
- Device Contamination with Chemical or Other Material11
- Retraction Problem10
- Crack9
Patient problems
- No Clinical Signs, Symptoms or Conditions155
- No Known Impact Or Consequence To Patient37
- No Consequences Or Impact To Patient15
- Insufficient Information8
- No Patient Involvement3
- Venipuncture2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Extravasation1
Recent adverse event reports
The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Leak/Splash
"DAMAGED ISOLATION PLUG DURING USE, RESULTING IN BLOOD LEAKAGE UNABLE TO RETURN DEFECTIVE PRODUCT, PHOTOGRAPHS AVAILABLE. GREEN CLAIM REQUIRED, COMPLAINT RESPONSE LETTER REQUIRED, COMPLAINT RECEIPT LETTER NOT REQUIRED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521554 ↗MalfunctionJun 5, 2026Separation Problem
WHEN IN USE, THE SAFETY DEVICE CANNOT BE REMOVED; THERE IS ONE DEFECTIVE UNIT. THE DEFECTIVE PRODUCT IS RETURNED, AND PHOTOGRAPHS ARE AVAILABLE. A CLAIM IS REQUIRED, ALONG WITH A RESPONSE LETTER TO THE COMPLAINT AND A RECEIPT OF COMPLAINT ACKNOWLEDGMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410411 ↗MalfunctionMay 28, 2026Leak/Splash
ON THESE IV'S THE SMALL EXTENSION IS PART OF A CLOSED SYSTEM ATTACHED TO THE IV CATHETER WITH WINGS. THE EXTENSION WAS LEAKING SO THE ENTIRE IV HAD TO BE TAKEN OUT AND REPLACED. THIS RENDERED PT'S VEIN UNUSABLE AND ANOTHER POINT OF ACCESS HAD TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321890 ↗MalfunctionApr 21, 2026Material Integrity Problem
IT WAS REPORTED THAT THE HUB WAS CRACKED AND LEAKED. ACCORDING TO THE CUSTOMER REPORT, THE CATHETER ADAPTER WAS CHIPPED. THE PATIENT WENT TO THE OPERATING ROOM WITH THE LINE SECURED FROM THE WARD. WHEN THE INFUSION LINE WAS CONNECTED, THE CATHETER ADAPTER WAS CHIPPED DURING USE. I WANT YOU TO INVESTIGATE WHETHER IT IS INSIDE OR OUTSIDE THE STANDARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945132 ↗MalfunctionFeb 11, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314358 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak
ISOLATION PLUG LEAKED BLOOD DURING USE, DEFECTIVE QUANTITY 1, DEFECTIVE PRODUCT CAN BE RETURNED, PHOTOS PROVIDED. CLAIMS NEED TO BE SETTLED, COMPLAINT RESPONSE LETTER NEEDED, COMPLAINT RECEIPT LETTER NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234907 ↗MalfunctionJan 23, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT BLOOD LEAKS OUT OF CONTROL PLUG THIS PRODUCT WAS USED WITH A LEAKAGE OF BLOOD FROM THE ISOLATION PLUG; QUANTITY AFFECTED 1 UNIT, SAMPLE CAN BE RETURNED, PHOTOS AVAILABLE; GREEN CLAIM REQUIRED, COMPLAINT RESPONSE LETTER REQUIRED, COMPLAINT RECEIPT LETTER REQUIRED NOTE: THIS PRODUCT HAS BLOOD LEAKAGE, CARE IS REQUIRED TO AVOID THE RISK OF INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163489 ↗MalfunctionJan 15, 2026Leak/Splash
DURING USE, THE ISOLATION PLUG LEAKED. NO HARM/INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079051 ↗MalfunctionJan 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT BLOOD LEAKS THIS BATCH NUMBER TODAY THERE ARE TWO MORE CASES OF ISOLATION PLUG LEAKAGE OF BLOOD. ************************************ THE PRODUCT WAS SUCCESSFULLY PUNCTURED, BUT AFTER REMOVING THE NEEDLE CONE, BLOOD LEAKAGE OCCURRED FROM THE ISOLATION PLUG; TWO UNITS WERE AFFECTED; SAMPLES CANNOT BE RETURNED, WITH PHOTOGRAPHIC EVIDENCE PROVIDED; REQUIRES A GREEN CLAIM; REQUIRES A COMPLAINT RESPONSE LETTER; REQUIRES A COMPLAINT RECEIPT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23978412 ↗MalfunctionJan 6, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23972929 ↗MalfunctionJan 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT LEAKED THIS PRODUCT WAS FOUND TO LEAK BLOOD FROM THE ISOLATION PLUG AFTER WITHDRAWAL OF THE NEEDLE CONE; AFFECTED QUANTITY 2 PCS, SAMPLES COULD NOT BE RETURNED AT THIS TIME, PHOTOS ARE AVAILABLE; GREEN CLAIM REQUIRED, COMPLAINT RESPONSE LETTER REQUIRED, COMPLAINT RECEIPT LETTER REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957613 ↗MalfunctionJan 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT BLOOD LEAKS OUT OF CONTROL PLUG BOSSES, THIS BATCH NUMBER HAS TWO MORE CASES OF ISOLATION PLUG LEAKING BLOOD IN THE PAST TWO DAYS, PLEASE ASSIST IN INVESTIGATING THE CAUSE AND GIVE CUSTOMERS A RESULT FEEDBACK, THANK YOU. THE PRODUCT WAS SUCCESSFULLY PUNCTURED, BUT AFTER REMOVING THE NEEDLE CONE, BLOOD LEAKAGE OCCURRED FROM THE ISOLATION PLUG; TWO UNITS WERE AFFECTED; SAMPLES CANNOT BE RETURNED, WITH PHOTOGRAPHIC EVIDENCE PROVIDED; REQUIRES A GREEN CLAIM; REQUIRES A COMPLAINT RESPONSE LETTER; REQUIRES A COMPLAINT RECEIPT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945700 ↗MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT BLOOD LEAKS OUT OF CONTROL PLUG THE PRODUCT WAS SUCCESSFULLY PUNCTURED, BUT AFTER REMOVING THE NEEDLE CONE, BLOOD LEAKAGE OCCURRED FROM THE ISOLATION PLUG; TWO UNITS WERE AFFECTED; SAMPLES CANNOT BE RETURNED, WITH PHOTOGRAPHIC EVIDENCE PROVIDED; REQUIRES A GREEN CLAIM; REQUIRES A COMPLAINT RESPONSE LETTER; REQUIRES A COMPLAINT RECEIPT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935715 ↗MalfunctionNov 25, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23650329 ↗MalfunctionAug 18, 2025Leak/Splash; Leak/Splash
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (B)(6) 2025 AFTER SUCCESSFUL PLACEMENT OF THE IV INTO THE PATIENT'S VEIN, WHILE FLUSHING FLUID THROUGH THE PORT, LEAKING OCCURRED. THE RN NOTICED A DEFECT WHERE THE PINK HUB CONNECTS TO THE CLEAR TUBING, CAUSING THIS LEAKING. THE IV WAS REMOVED AND A NEW IV WAS PLACED SUCCESSFULLY. I HAVE A SAMPLE ON HAND TO RETURN TO BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22830063 ↗MalfunctionAug 11, 2025Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773225 ↗MalfunctionJul 22, 2025Crack; Crack
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT ADAPTER / CONNECTOR DEFECTIVE / DAMAGED DURING USE, THE NEEDLE CONE CANNOT BE RETRIEVED. THE NUMBER OF AFFECTED PRODUCTS IS (B)($).. SAMPLES CAN BE RETURNED, AND PHOTOS ARE AVAILABLE. NO CLAIM IS NECESSARY, BUT THE RETURN AND EXCHANGE PROCESS MUST BE FOLLOWED. A COMPLAINT RESPONSE LETTER AND COMPLAINT RECEIPT LETTER ARE REQUIRED. IT HAS BEEN CONFIRMED WITH THE ESCALATION THAT THE AFFECTED NUMBER IS 60 THE FAULTS ARE: 1. SCREW ON THE HEPARIN CAP AND THE INDIVIDUAL INDWELLING NEEDLE WILL CRACK 2. UNABLE TO WITHDRAW THE NEEDLE CORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22567142 ↗MalfunctionJul 17, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA 20 CATHETER WAS DEFECTIVE DURING USE, THE NEEDLE CONE CANNOT BE RETRIEVED. NINE UNITS ARE AFFECTED, AND THE SAMPLES CAN BE RETURNED. PHOTOS ARE AVAILABLE. CLAIMS ARE REQUIRED, AND A COMPLAINT RESPONSE LETTER AND COMPLAINT RECEIPT LETTER ARE REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531905 ↗MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT TUBING BROKE/SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT IS AN ELDERLY WOMAN OF UNKNOWN AGE. THE BROKEN EXTENSION TUBE AND CATHETER HAVE BEEN DISCARDED (ONLY CONNECTOR PART WILL BE RETURNED). THERE IS NO BLOOD LEAKAGE OR DRUG LEAKAGE. IT WAS REPORTED THAT THE EXTENSION TUBE WAS CUT (FELL OUT?) FROM THE BASE OF THE CONNECTOR SECTION ON THE OPPOSITE SIDE OF THE WING. THERE IS NO EXTENSION TUBE BEYOND THE CONNECTOR WHEN CUSTOMER VISITED THE WARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22285821 ↗MalfunctionJun 17, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: ON (B)(6) 2025 - THE NEEDLE PIERCED THE SIDE OF THE CATHETER DURING PLACEMENT. A NEW IV WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236618 ↗MalfunctionMar 24, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT LEAKED COMPLAINT TO THE SAME PHENOMENON: THE VENT PLUG WAS NOT CONNECTED TO THE EXTENSION TUBE OF THE BD NEXIVA SINGLE PORT. WHEN THE USER OPENED THE STERIL PACKAGING SHE SAW THAT THE VENT PLUG WAS NOT CONNECTED TO THE LUER ADAPTER. IT LAY SEPERATELY IN THE STERIL PACKAGING, SEE THE ATTACHED PHOTOGRAPHY. IN A FEW MORE CASES THE USER DIDN'T NOTICE THIS AND INSERTED THE CATHETER INTO THE PATIENT'S VEINS. DURING THIS PROCEDURE THE BLOOD FLEW OUT OF THE EXTENSION TUBE OF THE NEXIVA SINGLE PORT WHEN DID THE INCIDENT OCCUR? BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527020 ↗MalfunctionMar 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE DISENGAGEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT - (B)(6)2025 - THIS IV WAS NOT PLACED INTO A PATIENT DUE TO THE GRINDING FELT WHEN PULLING THE NEEDLE PORTION BACK. I HAVE THE SAMPLE ON HAND TO RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504514 ↗MalfunctionJan 22, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA SINGLE PORT ADAPTER IS CRIMPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION PORT OF THE 20 GAUGE IV WAS CRIMPED AND UNABLE TO BE CONNECTED TO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PIV ACCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208169 ↗MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21191346 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.