UNKNOWN NEONATAL

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE LINES HAD AIR WHEN ASPIRATING BOTH IN VEINS AND ARTERIES WITH SOLUTION COMING OUT OF ONE SIDE. THERE WAS NO PATIENT HARM. THE ITEM CODE AND LOT NUMBER ARE UNKNOWN.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE THE ROOT CAUSE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. IT MUST BE NOTED THAT IN-PROCESS CONTROLS SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION, AND VISUAL ACCEPTANCE SAMPLING ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.