MANOMETER TRAY STERILE 10/BX - 4330

Additional Manufacturer Narrative

PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PRODUCT LEAKED. PRODUCT LEAKING. PER RESPONSE EMAIL: THE MANOMETER WAS LEAKING AT THE CONNECTION TO THE STOPCOCK. THERE WERE NO CRACKS OR BREAKS IN MANOMETERS THAT COULD BE VISUALIZED. INITIALLY WE TRIED USING ANOTHER MANOMETER , WHICH DID THE SAME THING. WE THEN HAD TO USE MORE FORCE FOR A TIGHTER SEAL. THAT SEEMED TO RESOLVE THE ISSUE BUT THEN IT IS DIFFICULT TO DISCONNECT MANOMETER/STOPCOCK. THE IMPACT TO PATIENT IS THAT IF IT LEAKS, WE CANNOT RECORD AN ACCURATE OPENING PRESSURE AND MANY OF THESE PATIENTS HAVE LUMBAR PUNCTURES ORDERED ALMOST EXCLUSIVELY FOR OPENING PRESSURE.

Additional Manufacturer Narrative

(B)(4). FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO OF THE PACKAGE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER: 0001414251 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT: SEE MANUFACTURER HERE.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PRODUCT LEAKED. PRODUCT LEAKING. PER RESPONSE EMAIL: THE MANOMETER WAS LEAKING AT THE CONNECTION TO THE STOPCOCK. THERE WERE NO CRACKS OR BREAKS IN MANOMETERS THAT COULD BE VISUALIZED. INITIALLY WE TRIED USING ANOTHER MANOMETER , WHICH DID THE SAME THING. WE THEN HAD TO USE MORE FORCE FOR A TIGHTER SEAL. THAT SEEMED TO RESOLVE THE ISSUE BUT THEN IT IS DIFFICULT TO DISCONNECT MANOMETER/STOPCOCK. THE IMPACT TO PATIENT IS THAT IF IT LEAKS, WE CANNOT RECORD AN ACCURATE OPENING PRESSURE AND MANY OF THESE PATIENTS HAVE LUMBAR PUNCTURES ORDERED ALMOST EXCLUSIVELY FOR OPENING PRESSURE.