Additional Manufacturer Narrative · 1
EVALUATION - OTHER: SMITHS MEDICAL IS UNABLE TO FULLY INVESTIGATE THIS REPORT. THE REPORTER HAS STATED THAT SHE IS NOT ALLOWED TO PROVIDE ME WITH ANY FURTHER DETAILS. WITHOUT DETAILS OF HOW EVENT OCCURRED, AND NO LOT NUMBER OR SAMPLE PROVIDED, WE ARE UNABLE TO FULLY INVESTIGATE. WHEN THE HOSP FIRST CONTACTED US THEY WANTED TO KNOW THE AMOUNT OF PRESSURE TO BE USED FOR THIS TYPE OF EVENT. FURTHER CONVERSATION THEY STATED THAT THEY WERE NOT USING PRESSURE BUT RATHER GRAVITY. A REVIEW OF OUR COMPLAINTS DATABASE REVEALS NO SIMILAR REPORTS OF BLADDER DISENGAGING ON THIS PRODUCT LINE. REVIEW OF REPORT WITH IN HOUSE CLINICIAN REVEALS THAT PRESSURE IS NOT TYPICALLY USED DURING BLADDER IRRIGATION. WE HAVE REQUESTED FURTHER INFO FROM THE RISK MGMT OF THE USER FACILITY. IF WE ARE PROVIDED WITH FURTHER DETAIL, THEN A FOLLOW-UP REPORT WILL BE PROVIDED.