JAMSHIDI BONE MARROW NEEDLES

Additional Manufacturer Narrative

(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

CUSTOMER STATED VIA EMAIL: THE BONE MARROW ASPIRATE NEEDLE BROKE AND STUCK IN PATIENT'S POSTERIOR ILIAC CREST. SURGERY CONSULTED. NO PATIENT HARM, BUT THE PATIENT DID HAVE TO GO TO THE OR TO GET IT REMOVED. THE DATE WAS (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED 6MAR2017: CAN YOU PLEASE PROVIDE PATIENT INFORMATION? I.E. INITIALS, AGE, GENDER, WEIGHT WE CANNOT PROVIDE THIS INFORMATION. CAN YOU PLEASE FIND OUT THE PRODUCT CODE/LOT NUMBER FOR THE DEFECTIVE PRODUCT? WE HAVE THE PRODUCT TO RETURN, BUT DO NOT HAVE THE PRODUCT CODE. APPROXIMATELY HOW LONG WAS THE RETAINED PIECE OF NEEDLE? UNABLE TO CONFIRM THE LENGTH OF THE PIECE OF RETAINED NEEDLE. (B)(6) MD, THE PHYSICIAN PERFORMING THE PROCEDURE STATED IN HER PROCEDURE NOTE, THE NEEDLE BROKE WITH 1-1.5 INCHES REMAINING IN THE PATIENT. WAS THE PATIENT'S STAY IN THE HOSPITAL EXTENDED DUE TO THE SURGICAL PROCEDURE TO REMOVE THE BROKEN NEEDLE? THE PATIENT HAD TO HAVE THE SURGICAL PROCEDURE, BUT HE WAS DISCHARGED TO HOME AFTER THE PROCEDURE, SAME DAY, IS MY UNDERSTANDING. THE IMPACT TO THE PATIENT INCLUDED THE NEED TO BE INTUBATED, HAVE EXTENDED ANESTHESIA AND AN OR PROCEDURE TO REMOVE THE RETAINED PORTION OF THE NEEDLE. WHAT IS THE STATUS OF THE PATIENT NOW IN RELATION TO THE REPORTED ISSUE? AS FOR STATUS OF THE PATIENT, HERE IS WHAT WAS NOTED IN THE POST OP NOTE: THE PATIENT LIVES IN FLORIDA. I WILL ATTEMPT TO DO A TELEMEDICINE-TYPE ENCOUNTER IN ABOUT A WEEK'S TIME. I AM HAPPY TO SEE HIM BACK WHEN HE RETURNS FOR A REPEAT BONE MARROW IN 6-8 WEEKS' TIME. SIGNED BY (B)(6) MD.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. THREE JAMSHIDI BIOPSY NEEDLES WERE RETURNED FOR ANALYSIS. ONE NEEDLE WAS BROKEN OFF AT APPROXIMATELY 1.5¿ FROM THE DISTAL END. THE TWO REMAINING NEEDLES WERE OBSERVED TO BE BENT. THEREFORE, THE REPORTED DEFECT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THAT ONE NEEDLE WAS BROKEN, AND TWO WERE BENT. THE DEVICE HISTORY RECORD FOR THESE COMPONENTS WAS UNAVAILABLE AS NO LOT NUMBER WAS REPORTED WITH THE COMPLAINT. THE RETURNED SAMPLES SHOWED SIGNS OF EXCESSIVE FORCE APPLIED TO THE NEEDLES CAUSING THE CANNULA OF THE NEEDLE TO BEND. HOWEVER, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A PROBABLE ROOT CAUSE DUE TO A LACK OF INFORMATION REGARDING THE SPECIFIC FORCES APPLIED TO THE RESPECTIVE NEEDLE DURING USE. A ROOT CAUSE COULD NOT BE ESTABLISHED, THEREFORE CORRECTIVE ACTIONS ARE NOT INDICATED. RECORD OF THE COMPLAINT WILL BE MADE IN THE COMPLAINT TRACKING SYSTEM. LIKEWISE, THE CUSTOMER WILL BE MADE AWARE OF THE SPECIFIC CAUTIONARY STATEMENT PROVIDED WITH THE INSTRUCTIONS FOR USE REGARDING THE APPLICATION OF EXCESSIVE FORCE DURING THE PLACEMENT AND REDIRECTION OF THE BONE MARROW BIOPSY NEEDLE. BD WILL CONTINUE TO TRACK AND TREND THIS FAILURE MODE.