BD Nexiva 383512Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 22 GA X 1 IN SINGLE PORT · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva IV catheter has 296 reports, including 7 injuries and no deaths. Many describe blood or fluid leaking from the catheter's septum or connections, and some describe difficulty activating the device. A few mention foreign material. 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
- 295
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 00382903835126), received between Nov 28, 2017 and Sep 24, 2026 — classified as 7 injuries, 288 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (89 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/Splash89
- Difficult or Delayed Activation27
- Device Contamination with Chemical or Other Material25
- Retraction Problem20
- Fluid/Blood Leak15
- Break14
- Material Puncture/Hole14
- Defective Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions172
- No Known Impact Or Consequence To Patient66
- No Consequences Or Impact To Patient23
- No Patient Involvement12
- Insufficient Information9
- Foreign Body In Patient4
- Extravasation3
- Needle Stick/Puncture2
Recent adverse event reports
The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884807 ↗MalfunctionJun 9, 2026Leak/Splash
THIS PRODUCT SUFFERED FROM BLOOD AND FLUID LEAKAGE FROM THE ISOLATION PLUG WHEN THE NEEDLE CORE WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446823 ↗MalfunctionJun 3, 2026Leak/Splash
THIS PRODUCT SUFFERED FROM BLOOD AND FLUID LEAKAGE FROM THE ISOLATION PLUG WHEN THE NEEDLE CONE WAS WITHDRAWN. NO MEDICATION WAS LOST; THE LEAK CONSISTED PRIMARILY OF BLOOD AND SALINE SOLUTION. THE CLIENT FIRST USED THE PRE-FILL FUNCTION TO VENT THE SYSTEM, THEN PERFORMED THE PUNCTURE. AFTER THE PUNCTURE WAS SUCCESSFUL, THE NEEDLE CONE WAS RETRIEVED, AT WHICH POINT A LEAK OCCURRED AT THE ISOLATION PLUG, RESULTING IN BLOOD AND FLUID LEAKAGE. THE CLIENT THEN REMOVED THE CANNULA AND PERFORMED THE PUNCTURE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382743 ↗MalfunctionMay 18, 2026Leak/Splash
THIS IS A REPORT ABOUT BLOOD LEAKAGE. ACCORDING TO THE CUSTOMER REPORT, THE BLOOD WAS LEAKING FROM THE BASE OF THE EXTENSION TUBE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200888 ↗MalfunctionMay 11, 2026Corroded; Contamination /Decontamination Problem
IT WAS REPORTED THAT FOREIGN MATTER WAS NOTED ON A NEEDLE. "NWWI HAS AN ISSUE WITH A LOT CONTAINING BLACK/METALLIC LOOKING COATING ON THE INSIDE PACKING OF THE STERILE NEEDLES. XXXXX HAS THESE NEEDLES SET ASIDE AND NEEDS INFORMATION TO SEND THEM BACK TO YOU FOR INVESTIGATION AND REPLACEMENT." "BLACK/METALLIC LOOKING COATING ON THE NEEDLE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137109 ↗MalfunctionMar 25, 2026Leak/Splash
IT WAS REPORTED THAT NEXIVA LEAKED AT THE SEPTUM. "IT WAS REPORTED THAT LEAKAGE HAS OCCURRED IN THE CATHETER SEPTUM DURING USE. PUNCTURE WAS PERFORMED TO FACILITATE A CONTRAST-ENHANCED CT SCAN. BACKFLOW OF BLOOD WAS OBSERVED EXTENDING THROUGH THE EXTENSION TUBE AND SLIGHTLY PAST THE SEPTUM¿A PHENOMENON THAT SHOULD NOT, UNDER NORMAL CIRCUMSTANCES, OCCUR. SINCE THE BACKFLOWING BLOOD DID NOT COMPLETELY BREACH THE SEPTUM OR LEAK OUTWARD, THE INSERTION PROCEDURE WAS CONTINUED, AND THE CATHETER WAS SUCCESSFULLY PLACED. FOLLOWING PLACEMENT, AS THE BACKFLOWING BLOOD STILL DID NOT FULLY BREACH THE SEPTUM OR LEAK EXTERNALLY, THE CONTRAST-ENHANCED CT SCAN WAS CARRIED OUT. THE CONTRAST-ENHANCED CT SCAN WAS COMPLETED WITHOUT INCIDENT. HOWEVER, AFTER THE SCAN WAS FINISHED, WHEN AN IV LINE WAS CONNECTED TO THE CATHETER ADAPTER AND FLUID INFUSION WAS INITIATED, THE FLUID LEAKED PAST THE SEPTUM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691082 ↗MalfunctionMar 18, 2026Leak/Splash; Nonstandard Device; Material Puncture/Hole
ACCORDING TO THE CUSTOMER REPORT, MEDICINE SOLUTION WAS LEAKING FROM THE NEXIVA CATHETER. AFTER NEXIVA IMPLANTATION, THE PATIENT OBSERVED REVERSE BLOOD LEAKAGE FROM THE CATHETER PORTION, AND WHEN THE CATHETER WAS REMOVED, DAMAGE WAS OBSERVED (NOT VISIBLE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631467 ↗MalfunctionMar 18, 2026Leak/Splash; Material Puncture/Hole; Material Integrity Problem
IT WAS REPORTED THAT NEXIVA TUBING HAD A HOLE. "PIV CATHETER SET- RN WENT TO STICK THE PATIENT, WHEN IN THE VEIN AND ATTEMPTING TO FLUSH, TUBING NOTED TO HAVE A HOLE. PIV REMOVED. AND NEW PIV SET OBTAINED AND PIV PLACED WITHOUT ISSUE.¿ ADDITIONAL INFORMATION 3/16/2026: NO SERIOUS INJURY OCCURRED TO THE PATIENT. WHEN IV WAS NOTED TO BE LEAKING/HAVE A HOLE, IT WAS REMOVED. THE PATIENT WAS STUCK AGAIN WITH A WORKING IV. THE ONLY RESULT WAS THE PATIENT NEEDED TO BE STUCK TWICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625985 ↗MalfunctionMar 6, 2026Device Contamination with Chemical or Other Material
BLACK RESIDUE ON OUTSIDE OF CATHETER. ONE IV WAS SUBSEQUENTLY REMOVED FROM PATIENT AFTER STAFF IDENTIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533785 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE NEEDLE BROKE. INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: NEEDLE BROKE OFF WHILE INSERTING IV CATH, PART OF NEEDLE IS STILL INSIDE THE CATH. ADDITIONAL INFORMATION 2/26/2026: PATIENT IMPACT: PATIENT NEEDED TO BE STUCK WITH A NEW IV CATH. DATE OF EVENT: 23-FEB-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498060 ↗MalfunctionMar 3, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496599 ↗MalfunctionFeb 23, 2026Device Contamination with Chemical or Other Material
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421905 ↗MalfunctionFeb 5, 2026Contamination /Decontamination Problem
IV NEEDLE WAS DEFECTIVE AND RAISED SERIOUS INFECTION CONCERNS AS IT HAD BLACK SUBSTANCE ON IT UPON INSPECTION. IV WAS NOT USED AND WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271761 ↗MalfunctionFeb 3, 2026Contamination
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248017 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT WHEN ATTEMPTING TO PUNCTURE THE PATIENT AND CONNECT THE IV FLUID SET, A LEAK WAS OBSERVED FROM THE BLUE PORTION AT THE BACK OF THE NEXIVA EXTENSION TUBE, AND ITS USE WAS DISCONTINUED (A RE-PUNCTURE WAS PERFORMED USING A DIFFERENT UNIT OF THE SAME PRODUCT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032052 ↗MalfunctionJan 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA 22 GA X 1 IN SINGLE PORT LEAKED DURING USE, THE PRODUCT EXPERIENCED LEAKAGE OF BLOOD FROM THE ISOLATION PLUG; ONE UNIT WAS AFFECTED, THE SAMPLE IS NOT RETURNABLE, AND PHOTOS ARE AVAILABLE; GREEN CHANNEL CLAIMS PROCESSING IS REQUIRED, ALONG WITH A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACKNOWLEDGMENT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24022371 ↗MalfunctionJan 2, 2026Material Split, Cut or Torn
WAS NOTICED DURING THE IV INSERTION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946531 ↗MalfunctionDec 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PIV INSERTED ON (B)(6). ON (B)(6), NOTED THAT CLOSED IV CATHETER SYSTEM, TUBING SEVERED. NOTED WHEN PIV FLUSHED WITH NORMAL SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908949 ↗InjuryDec 29, 2025Break; Break
WAS THE CATHETER BREAKAGE CONFIRMED THROUGH DIAGNOSTIC EVALUATION? YES. IF YES, WHAT DIAGNOSTIC METHOD OR TEST WAS USED TO VERIFY THE PRESENCE OF THE CATHETER FRAGMENT? THE ANESTHESIOLOGIST COMPLETED AN ULTRASOUND EXAMINATION WHICH CONFIRMED ¿HYPERECHOIC STRUCTURE APPROX. 10-15 MM IN LENGTH WITHIN LEFT FOREARM VEIN¿, THE CANNULA REMAINED IN THE PATIENT. WHAT PROCEDURE OR TECHNIQUE WAS EMPLOYED TO REMOVE THE CATHETER FRAGMENT FROM THE PATIENT? A CUTDOWN WAS PERFORMED TO REMOVE THE CANNULA.
Patient problems: Foreign Body In Patient
MAUDE report 23908248 ↗MalfunctionDec 16, 2025Break; Break
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822568 ↗MalfunctionDec 16, 2025Crack; Crack
THIS IS A COMPLAINT ABOUT BREAKAGE OF ONE-TOUCH CLAMP FOUND DURING USE. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND PUNCTURING, THE ONE-TOUCH CLAMP WAS FOUND TO BE DAMAGED DURING USE. THERE WAS NO ABNORMALITY IN THE PACKAGING CONDITION (E.G., DAMAGE TO PET).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817653 ↗MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496240 ↗MalfunctionOct 31, 2025Material Puncture/Hole; Material Puncture/Hole
THE FLEXIBLE CATHETER IS THE PART THAT BENT. THE NEEDLE APPEARS TO HAVE PUNCTURED THROUGH IT. THE NURSE SAID THAT SHE DIDN¿T DO ANYTHING DIFFERENTLY THAN INSERTIONS WITH THESE NEW IVS THAT SHE SUCCESSFULLY PLACED. CUSTOMER RESPONDED ON (B)(6) 2025 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO INJURY TO THE PATIENT. THE IV INSERTION ATTEMPT HAD TO BE ABORTED, HOWEVER, BECAUSE THE MALFUNCTION WOULD NOT ALLOW THE NURSE TO ADVANCE THE CATHETER. A SECOND RN PLACED A DIFFERENT IV FOLLOWING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442223 ↗MalfunctionOct 29, 2025Crack; Crack
THE DOCTOR REPORTED THAT THE HUB OF THE NEXIVA DEVICE CRACKED DURING FLUSHING AFTER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421048 ↗MalfunctionSep 17, 2025Material Separation; Material Separation
NURSE ATTEMPTING IV PLACEMENT WITH 22G CATHETER SYSTEM BD NEXIVA. THE J-LOOP OF THE IV SYSTEM COMPLETELY MALFUNCTIONED AND DISCONNECTED UPON PLACEMENT. HAD TO REMOVE THE IV.
Patient problems: Insufficient Information
MAUDE report 23074974 ↗
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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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