Insyte Autoguard 382957Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Winged Shielded IV Catheter Blood Control Technology 16 GA x 1.77 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903829576), received between Jul 3, 2025 and Jul 3, 2025 — classified as 1 injury.
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
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL WING CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: G16 WAS INTRODUCED TO PATIENT SKIN DURING INITIAL INSERTION. UPON SLOW RETRACTION OF THE CANNULA, NOTICED THAT HALF OF THE CANNULA WAS GONE. VERY MINIMAL BLOOD-TINGED WAS ON THE INSERTION SITE. CANNULA KEPT ASIDE. SECOND CANNULA, G18 WAS INSERTED ON THE RIGHT EJ VEIN WITH GOOD BACKFLOW, SECURED ACCORDINGLY. XRAY DONE ON THE RIGHT NECK, SEEN BY ICU DR AND CALLED GS. AT 0150H, GS CAME TO ASSESS THE PATIENT, XRAY SHOWED BY ICU DR. AT 0100H, REPEAT XRAY FOR THE RIGHT NECK WAS DONE BY TECH. NO NEW ORDERS MADE BY GS NOR ICU DR. CHARGE NURSE AWARE. CANNULA KEPT ASIDE. (CANNULA-BD INSYTE AUTOGUARDBC PRO WINGED G.16).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22394800 ↗
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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