SHUNT PAK, 11.5FR DOUBLE-VALVE

Additional Manufacturer Narrative

PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0401. PATIENT PROBLEM CODE: F1903.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO HAD A DENVER SHUNT PLACED IN MAY HAD A SHUNT INFECTION, SO IT WAS REMOVED. AT THAT TIME, CUSTOMER FOUND THAT THE CATHETER ON THE ABDOMINAL CAVITY SIDE WAS BROKEN. PLEASE INVESTIGATE THE CAUSE. LOT NUMBER 1508451. PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: WAS THE CATHETER BROKEN INSIDE THE ABDOMINAL CAVITY? YES, CATHETER CRACKED INSIDE THE ABDOMINAL CAVITY. WHEN WAS THE SHUNT PLACED? SHUNT PLACED IN (B)(6) 2024. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? REMOVED DUE TO SHUNT INFECTION. COULD YOU PLEASE CONFIRM THE LOT NUMBER 0001508451. 0001508451. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? SAMPLE WILL BE SENT FOR INVESTIGATION LATER.

Additional Manufacturer Narrative

(B)(4). FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A CUT WAS OBSERVED IN THE TUBING; THEREFORE, THE REPORTED FAILURE COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001508451 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. THERE STERILIZATION RECORD WAS REVIEWED, AND NO DEVIATIONS EXIST. THE STERILIZATION LOAD WAS PROCESSED AND RELEASED WITHOUT ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO HAD A DENVER SHUNT PLACED IN MAY HAD A SHUNT INFECTION, SO IT WAS REMOVED. AT THAT TIME, CUSTOMER FOUND THAT THE CATHETER ON THE ABDOMINAL CAVITY SIDE WAS BROKEN. PLEASE INVESTIGATE THE CAUSE. LOT NUMBER 1508451. PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: - WAS THE CATHETER BROKEN INSIDE THE ABDOMINAL CAVITY? YES, CATHETER CRACKED INSIDE THE ABDOMINAL CAVITY. - WHEN WAS THE SHUNT PLACED? SHUNT PLACED IN MAY 2024. - WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? REMOVED DUE TO SHUNT INFECTION. - COULD YOU PLEASE CONFIRM THE LOT NUMBER 0001508451. 0001508451. - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? SAMPLE WILL BE SENT FOR INVESTIGATION LATER.