JAMSHIDI NEEDLE BIOPSY 15G X 100MM DISP

Additional Manufacturer Narrative

(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 THAT CUSTOMER RECEIVED STERILE PRODUCT THAT HAS BEEN SEALED WITH A STRAND OF HUMAN HAIR. VERBATIM: ALSO, WE RECEIVED STERILE PRODUCT THAT HAS BEEN SEALED WITH A STRAND OF HUMAN HAIR. REF (B)(4), LOT 0001224605.

Description of Event or Problem

IT WAS REPORTED THAT CUSTOMER RECEIVED STERILE PRODUCT THAT HAS BEEN SEALED WITH A STRAND OF HUMAN HAIR. VERBATIM: ALSO, WE RECEIVED STERILE PRODUCT THAT HAS BEEN SEALED WITH A STRAND OF HUMAN HAIR. PLEASE PROVIDE ADDITIONAL DETAILS IN REGARD TO THE ISSUE? PRIOR TO OPENING, IT WAS DISCOVERED HAIR TO BE IN THE PACKAGE WITH PRODUCT. WAS THERE ANY PATIENT IMPACT OR DELAY IN TREATMENT? NO, THE PRODUCT IS STILL IN THE PACKAGE.

Additional Manufacturer Narrative

(B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHYSICAL SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE, THE FOREIGN MATTER WAS OBSERVED IN THE PACKAGING; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001224605 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 INFORMATION PROVIDED, A PROBABLE ROOT CAUSE WAS MANUFACTURING RELATED. AWARENESS TRAINING WAS CONDUCTED. 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. ONE PHYSICAL SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE, THE FOREIGN MATTER WAS OBSERVED IN THE PACKAGING; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001224605 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 INFORMATION PROVIDED, A PROBABLE ROOT CAUSE WAS MANUFACTURING RELATED. AWARENESS TRAINING WAS CONDUCTED. 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.