UNKNOWN DILATION PRODUCT

Description of Event or Problem

IT WAS REPORTED THAT CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT NO THEY WERE NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT BECAUSE NO. ADDITIONALLY STATED THAT NO THEY WERE NOT ABLE TO SUCCESSFULLY SUSTAIN PRESSURE, AND DEFLATE THE BALLOON BECAUSE NO. IN RELATION TO X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER WITHOUT EAGLE INFLATION DEVICE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

Additional Manufacturer Narrative

OUR TEAM CONDUCTED A REVIEW OF THE REPORTED EVENT, WITH THE AVAILABLE INFORMATION TO ENSURE THE ONGOING SAFETY AND PERFORMANCE OF THE PRODUCT. AS THIS INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT, ANOTHER INVESTIGATION IS NOT NECESSARY. AN INVESTIGATION HAS BEEN COMPLETED USING ALL INFORMATION CURRENTLY AVAILABLE. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. CORRECTIONS MADE TO TAB(S) E, F, H. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

Description of Event or Problem

IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY STATED THAT NO THEY WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT BECAUSE NO. ADDITIONALLY STATED THAT NO THEY WAS NOT ABLE TO SUCCESSFULLY SUSTAIN PRESSURE, AND DEFLATE THE BALLOON BECAUSE NO. IN RELATION TO X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER WITHOUT EAGLE INFLATION DEVICE.