JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP

Additional Manufacturer Narrative

(B)(4). THE ACTUAL NEEDLE INVOLVED IN THE EVENT WAS NOTED TO BE AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED AS OF YET. HOWEVER, EIGHTY-SEVEN UNOPENED SAMPLES FROM THE SAME LOT WERE RECEIVED FOR EVALUATION. DURING THE EVALUATION, NO MALFUNCTION OR MANUFACTURING DEFECT WAS NOTED THAT COULD LEAD TO THE REPORTED CONDITION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. SPECIFICALLY, AFTER THE NEEDLE IS ASSEMBLED, APPLICABLE MANUFACTURING PERSONNEL ARE REQUIRED TO PERFORM FUNCTIONAL TESTING AND TO VISUALLY VERIFY THE APPROPRIATE CONDITION OF THE NEEDLE PRIOR TO RELEASING IT TO THE NEXT STAGE IN THE PROCESS. IN ADDITION, NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. IT WAS DETERMINED THAT THE RAW MATERIAL USED TO MANUFACTURE THE CANNULA NEEDLE DID NOT CONTRIBUTE TO THE REPORTED CONDITION AS THE RAW MATERIAL USED PASSED ALL APPLICABLE QUALITY REQUIREMENTS. MOST PROBABLE CAUSE COULD NOT BE DETERMINED, AS DURING REVIEW OF THE APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCESSES, NO ISSUES WERE FOUND THAT COULD RELATE PERSONNEL, PROCESSES OR MATERIALS TO THE REPORTED CONDITION. IN ADDITION, ALTHOUGH THERE WAS NO EVIDENCE THAT THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) WERE NOT FOLLOWED PROPERLY, THE DESCRIPTION OF THE EVENT DID NOT MENTION THE ANGLE TO WHICH STEADY PRESSURE AND TWISTING MOTION WERE APPLIED. FOLLOWING VARIOUS SECTIONS OF THE IFU ARE CRITICAL TO THE PROPER USE OF THE PRODUCT AS THESE INDICATE THAT IF WHEN REDIRECTING THE NEEDLE (CANNULA), THE ANGLE DURING THIS PROCESS IS BEYOND 20 DEGREES, THIS COULD CAUSE THE NEEDLE (CANNULA) TO BEND OR BREAK. EVEN THOUGH THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED, IN ORDER TO PREVENT FUTURE OCCURRENCES, THE APPLICABLE MANUFACTURING PROCEDURE WILL BE MODIFIED TO SPECIFICALLY REQUIRE INSPECTION FOR BROKEN OR DAMAGED NEEDLES. IN ADDITION, THE MANUFACTURING LINE PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO RAISE AWARENESS. THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS. PLEASE NOTE THIS IS REPORT 1 OF 2 AS THERE WERE TWO NEEDLES INVOLVED IN THE EVENT.

Description of Event or Problem

DURING A PROCEDURE ON THE SAME PATIENT, THE NEEDLE TIP (EXTERNAL PART) OF TWO NEEDLES HAS BROKEN IN THE PATIENT BONE STRUCTURE, WHERE IT HAS REMAINED. CONSEQUENCE: X-RAY EXAMINATION TO MONITOR THE POSITIONING OF THE TWO NEEDLE PIECES REMAINED INSIDE THE PATIENT BONE STRUCTURE BODY. ON (B)(6) 2013, THE INTERNATIONAL CONTACT (B)(6) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE USER DID EXPERIENCE DIFFICULTY INSERTING THE NEEDLE INTO THE PATIENT AS THE BONE WAS RESISTANT. THIS WAS AN EXPERIENCED USER. THE BREAK OCCURRED DURING THE EXTRACTION. THE NEEDLE TIP IS IN THE PATIENT'S RIGHT ILIAC CREST. THERE WAS NOTHING NOTED OF THE NEEDLE PRIOR TO PATIENT USE THAT WOULD INDICATE A DEFECT. BESIDES THE X-RAY MONITORING, THERE WAS NO OTHER MEDICAL INTERVENTION AND THERE WAS NO PATIENT INJURY. THE PATIENT IS NOTED TO BE IN GOOD GENERAL CONDITION.

Additional Manufacturer Narrative

(B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE INVOLVED IN THE EVENT WAS RECEIVED FOR EVALUATION WITH ITS STYLET. THE SAMPLE WAS FOUND TO HAVE THE CANNULA BROKEN BUT THE STYLET WAS NOT BROKEN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. OTHER INVESTIGATION RESULTS HAVE ALREADY BEEN PROVIDED IN THE INITIAL MEDWATCH REPORT. PLEASE NOTE THIS IS REPORT 1 OF 2 AS THERE WERE TWO NEEDLES INVOLVED IN THE EVENT.