NIAGARA

Description of Event or Problem

IT WAS REPORTED THAT AT 10:00 ON (B)(6) 2025, WHEN A DIALYSIS TUBE WAS INSERTED INTO A PATIENT, WATER LEAKED FROM THE CONNECTION OF THE CANNULA, AFFECTING THE DIALYSIS EFFECT AND DELAYING THE TREATMENT PROCESS. AFTER THE LEAK OCCURRED, THE MEDICAL STAFF DEALT WITH IT IN A TIMELY MANNER, READJUSTED THE CONNECTION, AND REPLACED THE CATHETER OR CANNULA.

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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.