BD Nexiva 383516Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20 GA X 1 IN SINGLE PORT · Class 2
All models of BD Nexiva (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Nexiva is a short-term IV catheter. Many of its 288 reports describe blood or IV fluid leaking from the port or septum, and some describe the needle cutting through the tubing. The reports include 3 injuries and no deaths. One open recall began in October 2022 and concerns a tip shield that can separate during needle withdrawal, exposing the needle tip. Reports fell from 41 the year before to 22 in the latest 12 months.
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
- 294
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 00382903835164), received between Nov 8, 2017 and Sep 30, 2026 — classified as 3 injuries, 291 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (74 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Oct 12, 2022Class IIOpen, Classified
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Z-0174-2023 · Root cause: Storage · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash74
- Fluid/Blood Leak36
- Retraction Problem28
- Material Split, Cut or Torn19
- Difficult or Delayed Activation13
- Difficult or Delayed Separation13
- Device Contamination with Chemical or Other Material12
- Separation Failure12
Patient problems
- No Clinical Signs, Symptoms or Conditions169
- No Known Impact Or Consequence To Patient70
- Insufficient Information21
- No Consequences Or Impact To Patient11
- No Information5
- Pain5
- No Patient Involvement3
- Blood Loss2
Recent adverse event reports
The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954903 ↗MalfunctionSep 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952603 ↗MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935971 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921289 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875123 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874629 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874627 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779958 ↗MalfunctionSep 15, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50779955 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779953 ↗MalfunctionAug 28, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506885 ↗MalfunctionJun 26, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE SEPTUM. IV INSERTED AND IVF IS LEAKING OUT OF PORT THAT NEEDLE CAME OUT OF CUSTOMER RESPONSE ON 11-JUN-2026. THE EVENTS OCCURRED ON APPROXIMATELY (B)(6) 2026. AT THIS TIME, THERE WERE NO KNOWN PATIENT INJURIES OR LASTING HARM. HOWEVER, THE IVS WERE LEAKING EITHER BLOOD OR IV FLUIDS FROM THE PORT AFTER INSERTION, WHICH REQUIRED REMOVAL AND PLACEMENT OF A NEW IV CATHETER FOR THOSE PATIENTS. I HAVE RECEIVED THE RETURN LABEL AND CAN SEND CATHETERS FROM THIS LOT NUMBER IF YOU WOULD LIKE THEM FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636238 ↗MalfunctionJun 17, 2026Material Perforation
DETAILED INCIDENT DESCRIPTION: "DURING THE INSERTION OF THE PERIPHERAL VENOUS CATHETER (PVC), THE PATIENT EXPERIENCED A SHARP JOLT. UPON REMOVAL OF THE PVC, IT BECAME APPARENT THAT THE NEEDLE HAD SEVERED THE CATHETER TUBING¿SURELY THIS SHOULD NOT HAPPEN"? RESPONSE RECEIVED ON 6/2/2026 NURSE WROTE: "THE PATIENT TOLD ME THAT SHE FELT A KIND OF PINCHING SENSATION IN THE VEIN, WHICH STARTLED HER; THIS WAS NOTICEABLE FROM HER POSTURE AND REACTION." AFTER REMOVAL, THE ENTIRE CATHETER LENGTH WAS INTACT. THE NEEDLE PUNCTURED THE CATHETER. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534539 ↗MalfunctionJun 5, 2026Leak/Splash
WHEN THE STEEL NEEDLE WAS REMOVED, THE BLOOD VALVE WAS NOT ACTIVATED AND DID NOT STOP THE BLOOD FROM POURING OUT OF THE IV CATHETER. NEW IV NEEDED TO BE PLACED SINCE THE DEVICE WAS FAULTY WHICH IS POOR CUSTOMER SERVICE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. LUCKILY, NO PART OF THE IV CATHETER WAS LEFT IN THE PATIENT. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410405 ↗MalfunctionMay 29, 2026Fluid/Blood Leak
WHEN USED, THE ISOLATION PLUG OOZED BLOOD, CAUSING BLOOD TO BE SPRAYED ON THE NURSE'S CLOTHING, DEFECTIVE QUANTITY 1. UNABLE TO RETURN DEFECTIVE PRODUCT, NO PHOTOS AVAILABLE. CLAIMS NEED TO BE SETTLED, COMPLAINT RESPONSE LETTER NEEDED, COMPLAINT RECEIPT LETTER NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334275 ↗MalfunctionMay 28, 2026Leak/Splash
ISOLATION PLUG BLEEDS WHEN USED, DEFECTIVE QUANTITY 1. UNABLE TO RETURN DEFECTIVE PRODUCT, PHOTOGRAPHS AVAILABLE. CLAIMS NEED TO BE SETTLED, COMPLAINT RESPONSE LETTER NEEDED, COMPLAINT RECEIPT LETTER NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322556 ↗MalfunctionMay 28, 2026Leak/Splash
"DURING USE, BLOOD AND FLUID LEAKAGE OCCURRED FROM THE ISOLATION STOPPER; THREE UNITS WERE AFFECTED; ONE PHYSICAL DEVICE WAS RETURNED, AND PHOTOS AND VIDEOS ARE AVAILABLE; A GREEN CLAIM IS REQUIRED, ALONG WITH A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACKNOWLEDGMENT LETTER.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322543 ↗MalfunctionMay 14, 2026Leak/Splash; Component Missing
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176079 ↗MalfunctionMay 1, 2026Material Integrity Problem
IT WAS REPORTED BY CUSTOMER THAT ONE OF THE RNS IN SDS EXPERIENCED AN ISSUE WHEN ATTEMPTING TO ADVANCE AN IV IMMEDIATELY AFTER OBTAINING BLOOD RETURN. UPON REMOVAL, IT WAS NOTED THAT THE NEEDLE HAD PERFORATED THROUGH THE CATHETER. VERBATIM: COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 383516. QUANTITY AFFECTED: 1EA. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ONE OF THE RNS IN SDS EXPERIENCED AN ISSUE WHEN ATTEMPTING TO ADVANCE AN IV IMMEDIATELY AFTER OBTAINING BLOOD RETURN. UPON REMOVAL, IT WAS NOTED THAT THE NEEDLE HAD PERFORATED THROUGH THE CATHETER. THERE WAS NO PATIENT HARM, AND NO ADDITIONAL SIMILAR INCIDENTS HAVE BEEN REPORTED AT THIS TIME. CUSTOMER DISPOSITION REQUEST: CUSTOMER ONLY WISHES TO LOG WITH MANUFACTURER ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057245 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE CATHETER. THE NURSE OPENED THE IV PACKAGING TO START AN IV ON A PATIENT. SHE EXAMINED THE CATHETER AND NOTICED A CLEAR SUBSTANCE ON THE CATHETER AND IN THE PROTECTIVE PLASTIC PIECE COVERING THE NEEDLE. THE DATE OF OCCURRENCE WAS ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769032 ↗MalfunctionJan 29, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1 IN SINGLE PORT LEAKED. AFTER INSERTING THE NEEDLE INTO THE PATIENT, BLOOD AND FLUID LEAKAGE WAS OBSERVED AT THE TIP OF THE INDWELLING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210458 ↗MalfunctionJan 23, 2026Contamination /Decontamination Problem
TYPE OF INCIDENT/PROBLEM: A1. DEFECT (OBSERVED PRIOR TO USE). LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON - DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT DURING USE. INCIDENT DETAILS: THERE WAS A SMALL PLASTIC PIECE ON THE NEXIVA 20G IV ALONG THE PLASTIC CATHETER. IT WAS STUCK TO THE CATHETER WHEN THE COVER WAS TAKEN OFF. THE PLASTIC WAS SMALL AND COULD BE REMOVED EASILY. THIS WAS NOT USED. THIS SAME PROBLEM HAS BEEN NOTICED ON OTHER 20G NEXIVA IV'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164934 ↗MalfunctionJan 23, 2026Contamination /Decontamination Problem
DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026 TYPE OF INCIDENT/PROBLEM: A1. DEFECT (OBSERVED PRIOR TO USE) LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT DURING USE INCIDENT DETAILS: THERE WAS A SMALL PLASTIC PIECE ON THE NEXIVA 20G IV ALONG THE PLASTIC CATHETER. IT WAS STUCK TO THE CATHETER WHEN THE COVER WAS TAKEN OFF. THE PLASTIC WAS SMALL AND COULD BE REMOVED EASILY. THIS WAS NOT USED. THIS SAME PROBLEM HAS BEEN NOTICED ON OTHER 20G NEXIVA IV'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164921 ↗MalfunctionDec 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1 IN SINGLE PORT LEAKED. IT WAS REPORTED BY CUSTOMER THAT PROPER INSERTION PROCEDURE WAS PERFORMED AND IV INSERTED INTO PATIENT TO LEFT AC [ANTECUBITAL] WITH LAB DRAW. WHILE OBTAINING LABS, PORT LOCATED BELOW CATHETER WAS LEAKING BLOOD. FLUSHED IV CATHETER AND FLUIDS WERE ALSO LEAKING AT SAME SITE. ATTEMPTED TO TROUBLESHOOT CONNECTIONS OF IV BUT CATHETER CONTINUED TO LEAK; IV REMOVED FROM PATIENT INTACT. RCC RECEIVED A COMPLAINT VIA EMAIL. PROPER INSERTION PROCEDURE WAS PERFORMED AND IV INSERTED INTO PATIENT TO LEFT AC [ANTECUBITAL] WITH LAB DRAW. WHILE OBTAINING LABS, PORT LOCATED BELOW CATHETER WAS LEAKING BLOOD. FLUSHED IV CATHETER AND FLUIDS WERE ALSO LEAKING AT SAME SITE. ATTEMPTED TO TROUBLESHOOT CONNECTIONS OF IV BUT CATHETER CONTINUED TO LEAK; IV REMOVED FROM PATIENT INTACT. DEMONSTRATED ISSUE WITH CHARGE NURSE BY FLUSHING REMOVED IV CATHETER AND COMPARED TO ANOTHER PRODUCT OF THE SAME LOT NUMBER THAT DID NOT HAVE THIS ISSUE. PATIENT HAD TO HAVE ANOTHER IV INSERTED DUE TO FIRST IV MALFUNCTION. NO ISSUES WITH NEW IV ESTABLISHED WITH SAME LOT NUMBER AND NO OTHER ISSUES WITH CATHETER DURING SHIFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778634 ↗MalfunctionNov 28, 2025Fluid/Blood Leak
PROPER INSERTION PROCEDURE WAS PERFORMED AND IV INSERTED INTO PATIENT TO LEFT AC [ANTECUBITAL] WITH LAB DRAW. WHILE OBTAINING LABS, PORT LOCATED BELOW CATHETER WAS LEAKING BLOOD. FLUSHED IV CATHETER AND FLUIDS WERE ALSO LEAKING AT SAME SITE. ATTEMPTED TO TROUBLESHOOT CONNECTIONS OF IV BUT CATHETER CONTINUED TO LEAK; IV REMOVED FROM PATIENT INTACT. DEMONSTRATED ISSUE WITH CHARGE NURSE BY FLUSHING REMOVED IV CATHETER AND COMPARED TO ANOTHER PRODUCT OF THE SAME LOT NUMBER THAT DID NOT HAVE THIS ISSUE. PATIENT HAD TO HAVE ANOTHER IV INSERTED DUE TO FIRST IV MALFUNCTION. NO ISSUES WITH NEW IV ESTABLISHED WITH SAME LOT NUMBER AND NO OTHER ISSUES WITH CATHETER DURING SHIFT.
Patient problems: Insufficient Information
MAUDE report 23671506 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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