INSYTE AUTOGUARD
Received Jul 16, 2026 · Event occurred Jul 2, 2026
Report 1710034-2026-00801 · MDR key 25849856
Device
Generic name
Peripheral Iv Catheters
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
381412
Lot number
6020806
Product problems
- Retraction Problem
- Material Perforation
- Failure to Advance
Patient
Unknown
- Ecchymosis
- Perforation of Vessels
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD -INSYTE AUTOGUARD NEEDLE PIERCED THE CATHETER."WHEN STARTING AN IV I WAS GOT FLASH AND THE IV CATHETER FILLED UP WITH BLOOD AND WENT INTO THE PLASTIC HOLDING DEVICE. I WAS UNABLE TO THREAT THE IV INTO THE VEIN SO I TRIED TO RETRACT THE NEEDLE WITH THE INTENT OF FLUSHING THE IV IN. THE NEEDLE DID NOT RETRACT. WHEN I HELD THE CATHETER WITH ONE HAND AND WENT TO PULL OUT THE NEEDLE I WAS MET WITH RESISTANCE AND THE ENTIRE CATHETER WAS PULLED OUT. THE CATHETER UPON INSPECTION AFTER REMOVAL WAS PUNCTURED IN A DIFFERENT SPOT THAN THE NEEDLE ALMOST MAKING A V SHAPE WITH THE CATHETER ONE WAY AND THE NEEDLE THE OTHER. PICTURE AVAILABLE UPON REQUEST CATHETER AND NEEDLE NOT CONNECTED IN ONE PLACE. PT ARM THEN CONTINUED TO BRUISE SIGNIFICANTLY WITH BLOWN VEIN AND NEEDLE AND CATHETER IN DIFFERENT PLACES MOMENTARILY PRIOR TO REMOVAL."
Additional Manufacturer Narrative
G.4. K201075; K251654.B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.