Insyte Autoguard 382912Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Winged Shielded IV Catheter Blood Control Technology 24 GA x 0.75 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903829125), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2025Defective Device; Defective Device
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL WING CATHETER IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: INCIDENT DESCRIPTION: EMERGENCY SITUATION IN AN EMERGENCY ROOM: PAEDIATRIC PATIENT SEVERELY BURNT, SEVERAL ATTEMPTS AT VENOUS CANNULATION WITH THE DEVICE WERE PERFORMED BY EXPERIENCED HEALTH PERSONNEL (PAEDIATRICIAN, DOCTOR ANAESTHETIST, NEONATOLOGIST, PAEDIATRIC NURSE) WERE UNSUCCESSFUL. THE REASONS WERE: A. DIFFICULTIES IN THE SKIN TRANSITION. B. PLASTIC SHEATH OF THE NEEDLE PERMANENTLY IN THE VEIN CURLS OR HAS A BREAK IN CONTINUITY. C. THE END OPPOSITE THE NEEDLE, I.E. THE PIECE TO BE EXTRACTED IS TOO LONG AND TOO HEAVY, ALTERS THE BALANCE AND GRIP CHANNELLING, MAKING IT UNSUITABLE FOR THE ENDS HAND AND FOOT. D. HIGH RESISTANCE TO BLOOD FLOW WITHIN PLASTIC LUMEN PROBABLY DUE TO THE FACT THAT THE LUMEN IN TIP HAS A DIAMETER NI ARE: GREATER THAN THE LUMEN OF THE BASE. DEVICE AVAILABILITY: YES. PLACE AVAILABILITY: THE DEVICE IS NOT AVAILABLE. ARE AVAILABLE IN UO PS PIECES FROM THE SAME BATCH. ANY OTHER INFORMATION THE REPORTER WISHES TO PROVIDE TO THE MINISTRY OF HEALTH: HEALTH PERSONNEL HAVE COMPLAINED EXTENSIVE
Patient problems: Insufficient Information
MAUDE report 21137457 ↗
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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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