SPINAL NEEDLE 18GA 3.50 IN

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

NEEDLE FOUND RUSTY BEFORE USE.

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO AND TWO PHYSICAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, AN ORANGE/BROWN FOREIGN MATTER IS OBSERVED NEAR THE CANNULA TIP. CHARACTERIZATION TESTING WAS PERFORMED IN ATTEMPT TO IDENTIFY THE COMPOSITION, UNFORTUNATELY THE RESULTS WERE INCONCLUSIVE. BASED ON THE TEXTURE, COLOR, AND VISUAL CHARACTERISTICS, THE MATTER IS SUSPECTED TO BE RUST. IT WAS NOTED THE PACKAGING APPEARED TO HAVE A SLIGHTLY DIFFERENT TEXTURE AS IF IT HAD BEEN WET. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR THE LOT 2103018, NO DEVIATIONS OR NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS PROBLEM. THREE RETAINED SAMPLES OF THE LOT 2103018 WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED AND NO CORROSION OR OTHER CONTAMINATION WAS OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY INSPECTED THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, VERIFYING THAT ALL PRODUCT IS FREE FROM DAMAGE OR FOREIGN MATERIAL. WE HAVE REVIEWED THE STERILIZATION CYCLE AND INSPECTIONS FOR THIS LOT AND FOUND ALL RESULTS MET REQUIRED SPECIFICATIONS, NO ISSUES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INCOMING INSPECTION RECORDS AT THE DISTRIBUTION CENTER VERIFY NO ISSUES WERE IDENTIFIED FOR THE REPORTED BATCH. IT IS POSSIBLE THIS INCIDENT COULD BE RELATED TO THE TRANSPORT OR STORAGE CONDITIONS OF THE PRODUCT OUTSIDE OF OUR FACILITY, HOWEVER, THIS CANNOT BE VERIFIED. BASED ON OUR QUALITY TEAM'S INVESTIGATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED ON THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES.