Insyte Autoguard 381837Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ Shielded IV Catheter 20 GA x 1.88 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903818372), received between Jan 7, 2024 and Jan 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- Retraction Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER REMAINED IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FROM HOSPITAL HAD ISSUE WHILE USING THE IV CANNULA. THE CANNULA HAD ¿TISSUED¿ AND WAS TO BE REMOVED. UPON REMOVING THE IVC IT WAS NOTED THAT THE ¿STRAW¿ COMPONENT OF THE CANNULA DID NOT COME WITH THE BUNG ATTACHMENT AND WAS RETAINED IN THE PATIENT¿S VEIN. THIS REQUIRED SURGICAL INTERVENTION TO REMOVE. THE CANNULA HAD BEEN INSITU FOR APPROXIMATELY 72HOURS AND HAD BECOME OCCLUDED ¿ UNABLE TO FLUSH OR WITHDRAW BLOOD. ULTRASOUND CONFIRMED THAT THE ¿STRAW¿ COMPONENT HAD REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21220547 ↗MalfunctionJan 7, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: THE INSERTION OF THE INTRAVENOUS CATHETER IS COMPLETED, BUT THE NEEDLE CANNOT BE RETRACTED INTO THE PROTECTIVE SHEATH WHEN THE RETRIEVAL BUTTON IS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18461406 ↗
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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