INSYTE AUTOGUARD
Received Jul 21, 2026 · Event occurred Jul 16, 2026
Report 1710034-2026-00829 · MDR key 25896157
Device
Generic name
Peripheral Iv Catheters
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
382523
Lot number
6079125
Product problems
- Material Frayed
Patient
Not reported
- Perforation of Vessels
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC CATHETER FRAYED. IV IN AND ONCE FLUIDS OPENED IV BLOWN. SOME WERE FOUND TO HAS FRAYED PLASTIC THAT COVER THE CATHETER TIP. THIS HAS CAUSED MORE THAN ONE ATTEMPT TO START AN IV ON A PATIENT.
Additional Manufacturer Narrative
B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.G.4. K201075; K251654.H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.