SITE SCRUB IPA STERILE

Description of Event or Problem

IT WAS REPORTED BY CUSTOMER THAT THERE IS INCREASE IN FAILING MEMBRANES ON THEIR TEGO CONNECTORS. THE CUSTOMER USES TEGO NEEDLESS CONNECTORS ON ALL HEMODIALYSIS LINES. THEY STARTED USING SAFESCRUB AND SITESCRUB IN A TRIAL AND HAVE NOTICED AN INCREASE IN FAILING MEMBRANES ON THEIR TEGO CONNECTORS. THEY BELIEVE ITS ATTRIBUTED TO THE "VIGOROUS" SCRUBBING OF THE BD DISINFECTANT CAPS. FOLLOW UP RESPONSE RECEIVED O 19/08/2024 IT¿S HAPPENING AT RANDOM ON A FEW DIFFERENT OCCASIONS AND ACROSS SEVERAL LOT NUMBERS. THE EVENT WAS DURING PATIENT USE. THERE WAS NO PATIENT INJURY BUT THE NURSES HAD TO CHANGE THEIR TEGO CONNECTORS OUT WHICH WAS AN ADDITIONAL WORKLOAD TO THEM. THE BD PRODUCT IS NOT DAMAGED. THE DAMAGE WAS TO THE TEGO NEEDLESS CONNECTOR. THE CUSTOMER BELIEVES OUR SCRUB CAP CAUSED DAMAGE TO THE MEMBRANE DUE TO THE FOAM FINGERS AND ¿VIGOROUS¿ SCRUB OF THE DEVICE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.