Insyte Autoguard 381934Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ Winged Shielded IV Catheter 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903819348), received between Jul 10, 2019 and Jun 23, 2026 — classified as 3 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
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026
WHEN INSERTING THE IV, THE TIP OF THE IV WENT IN, BUT UNABLE TO ADVANCE FURTHER. 2ND IV ATTEMPTED WITH DIFFERENT LOT NUMBER WITHOUT DIFFICULTY AND IV WAS SUCCESSFULLY PLACED. OTHER STAFF REPORTED SEVERAL INSTANCES OF SAME ISSUE WITH IV CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592458 ↗MalfunctionJan 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED HUB DOES NOT HAVE THREADS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (B)(6) 2024 TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE LEVEL OF HARM- MINIMAL HARM THERE IS NO THREADING ON THE PINK CATHETER PIECE THE PT BLED EVERYWHERE DUE TO THE HEPLOCK NOT BEING TO TWIST ON. WHO WAS AFFECTED? PATIENT UNEXPECTED OR PROLONGED CARE? YES. FREQUENCY OF PROBLEM: RECURRING. 30 DEC: WHAT WAS THE IMPACT TO THE PATIENT? BLEEDING AND HAVING TO RESTART IV AS NO THREADING DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. BLEEDING AND HAVING TO RESTART IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067055 ↗MalfunctionJul 10, 2019Break; Break
IT HAS BEEN REPORTED THAT ONE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD HAS EXPERIENCED PROBLEMS WITH THE SHEATH BONDED TO THE NEEDLE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CANNOT PULL CATHETER NEEDLE. CANNOT PULL NEEDLE FROM CANNULA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8777441 ↗
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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