Insyte Autoguard 382934Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Winged Shielded IV Catheter Blood Control Technology 20 GA x 1.16 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903829347), received between Mar 20, 2024 and Apr 17, 2026 — classified as 1 injury, 4 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
- Connection Problem1
- Contamination1
- Material Puncture/Hole1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Retraction Problem
IT WAS REPORTED THAT NEEDLES DID NOT FULLY RETRACT. YESTERDAY, THERE WERE TWO IV CATHETERS WHERE, WHEN THE WHITE BUTTON WAS PRESSED, THE NEEDLE DID NOT RETRACT FULLY INTO THE SHEATH. RESPONSE RECEIVED ON: (B)(6) 2026 "THERE WAS NO HARM DONE TO ANY PERSON. IT WAS JUST A SHORTAGE THAT WAS NOTICED BIJ SOME NURSES.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913795 ↗MalfunctionFeb 10, 2026Contamination
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306407 ↗MalfunctionMar 3, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL WING PIV ADAPTER- IV TUBING DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: KT IV (PINK CATHETER WITHOUT WINGS) FITTED THIS LUNCHTIME TO A PATIENT, CATHETER WELL FIXED AND PASSING WELL. THIS EVENING, THE INFUSION TUBING (PERFUSEUR GRAVITE 3VOIES R30CM DECONNECTABLE PER3FL25BPAF - DIDACTIC) UNSCREWED FROM THE CATHETER. HYDRATION PASSED BY. IT'S NOT THE FIRST TIME THIS HAS HAPPENED AND THE RISK OF HAEMORRHAGE IS +++. SEVERAL REPORTS PLEASE GIVE US YOUR ANALYSIS OF THIS FAULT AND LET US KNOW IF YOU HAVE RECEIVED ANY SIMILAR REPORTS FROM OTHER USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505587 ↗InjurySep 20, 2024Break; Break
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL WING CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY ENCOUNTERED A CRITICAL ISSUE WITH ONE OF YOUR PRODUCTS, SPECIFICALLY THE PINK CANNULA USED FOR BLOOD CONTROL. DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CANNULA HAD BROKEN OFF INSIDE THE PATIENT¿S BODY. A SUBSEQUENT CT SCAN CONFIRMED THE PRESENCE OF THE CANNULA FRAGMENT INSIDE THE PATIENT. THIS NECESSITATED AN ADDITIONAL SURGERY TO REMOVE THE BROKEN PIECE.
Patient problems: Foreign Body In Patient
MAUDE report 20273390 ↗MalfunctionMar 20, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DESCRIPTION : PINK CATHE PROBLEM BECAUSE THE METAL GUIDE CROSSES THE PLASTIC TEFLON ABOUT ABOUT 5 MM BEFORE THE END OF THE TEFLON. THE TEFLON DOES NOT SLIDE WELL AROUND THE METAL GUIDE CIRCUMSTANCES OF OCCURRENCE / DESCRIPTION OF FACTS: WHILE TRYING TO REPERFUSE A PATIENT, I REPEATEDLY HAD A KT LOX206A PROBLEM. THE METALLIC FLUID PASSES THROUGH THE PLASTIC TEFLON ABOUT 5MM HAD THE END TO THE TEFLON. THE TEFLON DOESN'T GRIP WELL AROUND THE METAL GUIDE. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: PRESERVED MEDICAL DEVICES WITHDRAWAL OF IS CONCERNED IN EFFECTIVE RESPONSE. FEI + REPORTING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18947071 ↗
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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