BD Nexiva, BD Q-Syte 383530Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 24GA 0.56IN Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903835300), received between Dec 11, 2020 and Jan 27, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
Most reported problems
Device problems
- Break1
- Contamination1
- Device Markings/Labelling Problem1
- Inaccurate Information1
- Leak/Splash1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21247073 ↗MalfunctionApr 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT 20 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WERE NOT LABELLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE INDIVIDUAL PACKAGES (X20) ARE NOT LABELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16804431 ↗MalfunctionDec 12, 2022Contamination; Contamination
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE SEAL WAS COMPROMISED. THIS OCCURRED 72 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND 72 DAMAGE PACKAGES OF NEXIVA DUAL PORT 0.56" SO CUSTOMERS CONCERNED ABOUT STERILITY AND CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965532 ↗MalfunctionAug 5, 2022Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT CUSTOMER RECEIVED UNIT PACKAGING THAT HAS A DIFFERENT DEVICE IDENTIFICATION THAN THE BOX OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: ISSUE AS THEY PACKED A 24 G BOX WITH 22 G. THE MATERIAL NUMBER THAT WAS ORDERED WAS 383530. THE MATERIAL/LOT NUMBER THAT WAS RECEIVED WAS 383530 AND THE LOT IS 2062925. THE PACKAGE LABEL ON THE OUTSIDE OF THE BOX IS LABELED AS 24G 0.56 IN IVS. THE PRODUCT INSIDE THE BOX IS MATERIAL NUMBER 383532 AND THE LOT NUMBER IS 2062951.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174607 ↗MalfunctionMar 9, 2022Missing Information; Missing Information
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM A LABEL WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME PACKAGES WERE ALSO UNPRINTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13715640 ↗MalfunctionDec 11, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.56 IN EXPERIENCED DEFECTIVE/DAMAGED TUBING AND LEAKAGE FROM TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PHARMACY MANAGER INFORMED BD OF AN ISSUE THAT HAPPENED WITH A PRODUCT. 383530 LOT 9144509 WAS INSERTED INTO THE PATIENT. THE TUBING HAD A PIN HOLE IN IT AND BLOOD LEAKED THRU IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10991556 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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