POWERGLIDE PRO

Description of Event or Problem

IT WAS REPORTED "I WAS TRAINING A NURSE ON ULTRASOUND GUIDED IVS USING OUR POWERGLIDE. AFTER AN UNSUCCESSFUL INSERTION ATTEMPT ON A PATIENT, WE PULLED OUT THE DEVICE TO FIND THAT THE GUIDEWIRE HAD BEEN SHEARED. THE DIRECT IMPACT WAS A BLOWN VEIN. HOWEVER, NO MEASURES WERE NEEDED TO BE TAKEN TO RESOLVE THIS. WE DEFERRED TO THE PICC NURSE TO COMPLETE THE PROCEDURE INSTEAD OF TRYING AGAIN." NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.