ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN

Description of Event or Problem

DURING THE BIOPSY, BLOOD CAME UP WITH THE HANDLE. AS A RESULT THE BIOPSY COULDN'T BE CONDUCTED AND HAD TO BE DONE WITH A NEW SET.

Additional Manufacturer Narrative

(B)(4): FOLLOW UP EMDR FOR DEVICE EVALUATION. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS EVIDENCE OF BLOOD ON THE EXTERNAL PART OF THE NEEDLE, VERIFYING THE REPORTED INCIDENT. DURING OUR EVALUATIONS THERE WAS NO FUNCTIONAL DEFECTS OR DAMAGE OBSERVED ON THE PRODUCT. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR REPORTED LOT 0001318524 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. A REVIEW OF MACHINE RECORDS VERIFIED THAT ALL QUALITY TESTING WAS PERFORMED ACCORDING TO PROCEDURE AND MACHINE PARAMETERS WERE WITHIN REQUIRED LIMITS. PRODUCT UNDERGOES VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS DURING MANUFACTURING, NO ISSUES THAT COULD RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE INCLUDED WITH THE PRODUCT TO ENSURE THE DEVICE FUNCTIONS PROPERLY. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

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

DURING THE BIOPSY, BLOOD CAME UP WITH THE HANDLE. AS A RESULT THE BIOPSY COULDN'T BE CONDUCTED AND HAD TO BE DONE WITH A NEW SET