BD Nexiva 383550Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 24 GA X 0.56IN SP WITH MAXZERO · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903835508), received between Jun 7, 2019 and Apr 20, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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/Splash3
- Device Contamination with Chemical or Other Material2
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burning Sensation1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Leak/Splash
IT WAS REPORTED THAT THE CATHETER LEAKED. LEAKING CATHETER. ADDITIONAL INFORMATION 04/16/2026: WHERE ON THE DEVICE THE LEAKAGE OCCUR? WHERE THE IV CATHETER INSERTS INTO THE CLEAR PLASTIC ABOVE THE YELLOW WINGS. WAS ANY MEDICATION BEING ADMINISTERED, IF SO WHAT WAS IT? UNKNOWN. DID ANYTHING ELSE HAPPEN TO THE PATIENT BESIDES NEEDING ANOTHER DEVICE? NOT THAT WE ARE AWARE OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931845 ↗MalfunctionJul 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD DEVICES LEAK IN THE SAME PLACE ON THE EXTENSION TUBING.
Patient problems: Insufficient Information
MAUDE report 22593981 ↗MalfunctionMay 20, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO CATHETER HAD A HOLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING THE CATHETER OF THE INTRAVENOUS (IV) INTO THE VEIN OF A 36-DAY-OLD PATIENT, THERE WAS VISIBLE FLASHBACK. THE GREY SAFETY LOCK WAS RETRACTED, AND IT WAS NOTED THAT THERE WAS A HOLE IN THE SIDE OF THE CANNULA AT THE INSERTION SITE. BLOOD WAS FOUND TO BE LEAKING FROM THE HOLE. THE IV SYSTEM WAS REMOVED, AND ANOTHER IV ATTEMPT WAS REQUIRED. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19352249 ↗MalfunctionJul 17, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING INSERTION THE NEEDLE WENT THROUGH THE CATHETER WITH A BD NEXIVA 24 GA X 0.56IN SP WITH MAXZERO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PRE-PROCEDURE NURSE INSERTED A PIV ON A PT PRE PROCEDURE IN IRU. BEFORE SHE INSERTED THE NEEDLE, IT DIDN¿T LOOK LIKE THERE¿S AN ISSUE WITH IT. HOWEVER, AS SOON AS SHE INSERTED IT ON A PATIENT, THE PT COMPLAINED OF BURNING PAIN. THE NURSE DECIDED THEN TO PULL OUT THE NEEDLE FROM THE PATIENT AND NOTED THAT THE PLASTIC SPLIT IN HALF AND THE ACTUAL METAL NEEDLE IS OUTSIDE THE PLASTIC.
Patient problems: Burning Sensation; Pain
MAUDE report 8798485 ↗MalfunctionJun 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD NEXIVA CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿ NEEDLELESS CONNECTOR 24 GA 0.56 IN (0.7 X 14 MM) EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383550. BATCH NO: 7300656. PER CUSTOMER EMAIL: I RECEIVED A CALL THIS AFTERNOON FROM A USER FACILITY WITH A CONCERN REGARDING MATERIAL 383550. THE NURSE STATES THAT WHEN THEY WERE USING THE BUTTERFLY ON THE PATIENT THERE WAS A YELLOW PLASTIC MATERIAL BY THE WINGS OF THE PRODUCT. NOT KNOWING WHAT THEY PLASTIC MATERIAL WAS, THEY REMOVED THE PRODUCT FROM THE PATIENT AND HAVE SET IT ASIDE TO HAVE IT REVIEWED BY BD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680193 ↗
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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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