LUMBAR PUNCTURE TRAY ADULT

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THEY WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THE WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE FURTHER DETAILS COULD BE OBTAINED FROM XXX

Additional Manufacturer Narrative

(B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001452437 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. 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. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.

Additional Manufacturer Narrative

(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0504. PATIENT PROBLEM CODE: F24.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THEY WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE FURTHER DETAILS COULD BE OBTAINED FROM XXX.