BD Nexiva 383572Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 22GA X 1.00 IN DP WITH MAXZERO · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903835720), received between Sep 1, 2021 and Feb 2, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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/Splash2
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
- Flushing Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Leak/Splash; Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA 22GA X 1.00 IN DP WITH MAXZERO LEAKED IT WAS REPORTED THAT "TWO MEDICAL DEVICE INCIDENTS THAT OCCURRED ON (B)(6) 2025 AND (B)(6) 2026 IN THE MEDICAL IMAGING DEPARTMENT OF (B)(6) HOSPITAL." THESE INCIDENTS CONCERN THE SAME MEDICAL DEVICE: - NAME: NEXIVA BLUE 22G POSITIVE PRESSURE VALVE PERIPHERAL VENOUS CATHETER - SUPPLIER REFERENCE: 383572 - BATCH NUMBER: 4220636 DESCRIPTIONS OF THE INCIDENT ON (B)(6) 2025 : "HEAVY BLEEDING DURING PATIENT INFUSION. MERM RINSED TO SEE WHAT WAS HAPPENING. LEAKAGE OF SALINE SOLUTION. SYSTEM NOT PERMEABLE WITH A ¿HOLE¿. DESCRIPTION OF THE INCIDENT ON (B)(6)2026: ¿WHILE INSERTING THE CATHETER INTO THE PATIENT, THE NEEDLE WENT THROUGH THE CATHETER, FORCING ME TO REINSERT THE PATIENT.¿ THE DEVICES ARE AT THE PHARMACY AND ARE AVAILABLE IF YOU WISH TO TAKE THEM BACK FOR EXAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235187 ↗MalfunctionJun 27, 2024Component Missing; Component Missing
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629503 ↗MalfunctionFeb 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
RESPONSE RECEIVED. 1. ARE YOU ABLE TO PROVIDE CORRECTED BATCH / LOT INFORMATION REPORTED? 3122730. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717015 ↗MalfunctionJan 26, 2024
PLASTIC CASING INTEGRITY WAS CLOUDY & IN QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18586759 ↗MalfunctionSep 10, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT NEXIVA 22GA X 1.00 IN DP WITH MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER IS EXPERIENCING LEAKAGE. MAXZERO IVS THAT WE ARE USING DO NOT ALLOW US TO CONNECT AND DISCONNECT WITHOUT HAVING DRIPS OF FLUID ON THEM. I HAVE TIGHTENED THEM BUT WHEN WE DISCONNECT FROM THE HUB, THERE ARE STILL DRIPS OF LIQUID. WE ARE USING RADIOACTIVE MATERIAL FOR THIS. ALSO THE SPONGE PART OF THE HUB, THE ACTIVITY IS GETTING HUNG UP IN THERE. WE HAVE TO FLUSH IT PROFUSELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12452925 ↗MalfunctionSep 10, 2021Flushing Problem; Flushing Problem
IT WAS REPORTED THAT NEXIVA 22GA X 1.00 IN DP WITH MAXZERO HAD INCOMPLETE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER IS EXPERIENCING LEAKAGE. MAXZERO IVS THAT WE ARE USING DO NOT ALLOW US TO CONNECT AND DISCONNECT WITHOUT HAVING DRIPS OF FLUID ON THEM. I HAVE TIGHTENED THEM BUT WHEN WE DISCONNECT FROM THE HUB, THERE ARE STILL DRIPS OF LIQUID. WE ARE USING RADIOACTIVE MATERIAL FOR THIS. ALSO THE SPONGE PART OF THE HUB, THE ACTIVITY IS GETTING HUNG UP IN THERE. WE HAVE TO FLUSH IT PROFUSELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12452923 ↗MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED WHEN USED WITH THE MAXZERO IVS, WHICH WERE DIFFICULT TO CONNECT/DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAXZERO IVS THAT WE ARE USING DO NOT ALLOW US TO CONNECT AND DISCONNECT WITHOUT HAVING DRIPS OF FLUID ON THEM. I HAVE TIGHTENED THEM BUT WHEN WE DISCONNECT FROM THE HUB, THERE ARE STILL DRIPS OF LIQUID. WE ARE USING RADIOACTIVE MATERIAL FOR THIS. ALSO THE SPONGE PART OF THE HUB, THE ACTIVITY IS GETTING HUNG UP IN THERE. WE HAVE TO FLUSH IT PROFUSELY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12405182 ↗
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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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