NIAGARA

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.

Description of Event or Problem

IT WAS REPORTED THE PHYSICIAN OBSERVED EXCESSIVE AIR BUBBLES DURING ASPIRATION AFTER THE PUNCTURE, SUSPECTING ENTRY INTO THE PLEURAL CAVITY. THE NEEDLE WAS IMMEDIATELY WITHDRAWN. SUBSEQUENT REPEATED ASPIRATIONS YIELDED AIR BUBBLES, NECESSITATING MULTIPLE NEEDLE WITHDRAWALS, ULTIMATELY RESULTING IN A FAILED PUNCTURE. UPON CLOSE INSPECTION OF THE GUIDE NEEDLE, A CRACK WAS FOUND AT THE NEEDLE STOPPER. A TEST ASPIRATION REVEALED THAT THE BUBBLES WERE CAUSED BY THIS CRACK. CONSEQUENTLY, THE SYRINGE HAD A DEFECT, CAUSING AIR LEAKAGE AND DIFFICULTY IN ASPIRATING FLUID. THE CANNULATION SET WAS THEREFORE DISCARDED. THIS ISSUE DIRECTLY RESULTED IN THE SCRAPPING OF THE NEWLY ESTABLISHED CANNULATION. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.