SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN

Description of Event or Problem

AFTER DR "[NAME REDACTED]" APPLIED THE SURGIFLO, HE COMPLAINED THAT THE CONSISTENCY SEEMED VERY SOLID-LIKE, AND THE GRANULES WERE VERY STICKY AND HARD TO IRRIGATE AWAY. HE ALSO COMMENTED THAT THE PRODUCT DID NOT HELP WITH HEMOSTASIS, BECAUSE THE SITE KEPT BLEEDING EVEN AFTER HE APPLIED SURGIFLO. HE APPLIED THE PRODUCT FOUR TIMES, AND HE ENSURED THAT HE ADHERED TO THE IFU RECOMMENDATION OF 2 MINUTES + TAMPONADE, BUT EVEN SO, THE BLEEDING DID NOT STOP. AFTER 30 MINUTES OF ATTEMPTED HEMOSTASIS, HE OPENED FLOSEAL AND USED THAT TO STOP THE BLEEDING. SINCE HIS OTHER EXPERIENCES WITH SURGIFLO HAD BEEN FINE THUS FAR (ONE APPLICATION OF PRODUCT IS USUALLY ENOUGH TO STOP THE BLEEDING), HE THINKS THAT THERE MAY BE AN ISSUE WITH THIS PRODUCT OR BATCH. I WAS SUPPORTING THE CASE, SO I CAN VOUCH THAT THE PRODUCT PREPARATION BY THE SCRUB NURSE WAS CORRECT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO WAS THERE A SIGNIFICANT DELAY? YES HOW LONG WAS THE DELAY (MINUTES)? 35