BD POSIFLUSH-SAFESCRUB, 10 ML (US/CA)

Additional Manufacturer Narrative

(B)(4) FOLLOW UP. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 303191, LOT: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THERE IS INCREASE IN FAILING MEMBRANES ON THEIR TEGO CONNECTORS. THE CUSTOMER USES TEGO NEEDLESS CONNECTS 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 ON 19/08/2024. HI TEAM, I DO NOT HAVE A LOT NUMBER FOR EITHER OF THE DEVICES. IT¿S HAPPENING AT RANDOM ON A FEW DIFFERENT OCCASIONS ACCORDING TO THE CUSTOMER WHICH TELLS ME ITS ACROSS SEVERAL LOT NUMBERS. YES, 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. THANK YOU! (B)(6). TERRITORY MANAGER - ONCOLOGY & VASCULAR CARE. (B)(6).

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

MATERIAL: 303191 LOT: UNKNOWN. 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 SAFE SCRUB AND SITE SCRUB 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 ON (B)(6) 2024 HI TEAM, I DO NOT HAVE A LOT NUMBER FOR EITHER OF THE DEVICES. IT¿S HAPPENING AT RANDOM ON A FEW DIFFERENT OCCASIONS ACCORDING TO THE CUSTOMER WHICH TELLS ME ITS ACROSS SEVERAL LOT NUMBERS. YES, 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. THANK YOU! (B)(6) TERRITORY MANAGER - ONCOLOGY & VASCULAR CARE (B)(6).