JAMSHIDI NEEDLE BONE MARROW 11GX6 ASP

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: ONE SAMPLE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION, IT WAS NOTED THAT THE CANNULA NEEDLE WAS BROKEN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. SPECIFICALLY, MANUFACTURING AND INSPECTION PROCEDURES REQUIRE PERSONNEL TO VERIFY THAT EACH NEEDLE FUNCTIONS AS INTENDED PRIOR TO RELEASE OF THE PRODUCT. NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL AND COMPONENTS USED DURING THE MANUFACTURE OF THE LOT INVOLVED. IN ADDITION, EVEN THOUGH THERE WAS NO EVIDENCE THAT INSTRUCTIONS WERE NOT FOLLOWED PROPERLY, THE DESCRIPTION OF THE EVENT DID NOT MENTION THE ANGLE TO WHICH THE STEADY PRESSURE AND TWISTING MOTION WERE APPLIED, AND SECTION #7, #13 AND #14 OF THE PRODUCT¿S INSTRUCTIONS FOR USE ARE CRITICAL TO THE PROPER USE OF THE NEEDLE. THE INSTRUCTIONS STATE 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. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED, AS DURING REVIEW OF THE APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCESSES, NO ISSUES WERE FOUND THAT COULD RELATE PERSONNEL, MANUFACTURING METHOD OR MATERIALS TO THE REPORTED CONDITION. THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS RECEIVED VIA AN FDA ADDITIONAL INFORMATION LETTER RECEIVED ON (B)(6) 2013, REFERENCING VOLUNTARY REPORT NUMBER MW5032738: DURING A BONE MARROW BIOPSY, THE JAMSHIDI ASPIRATION NEEDLE BROKE IN HALF. PART OF THE NEEDLE REMAINED IN THE PATIENT'S ILIAC CREST AND REQUIRED SURGICAL REMOVAL. THE DEVICE IS NOTED TO BE AVAILABLE. ON (B)(6) 2013, THE CUSTOMER ((B)(6)) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THIS IS AN EXPERIENCED USER OF THE DEVICE. THE ONCOLOGIST INSERTED THE CANNULA AND STYLET WITHOUT DIFFICULTY. THE BONE WAS NOT HARDER THAN EXPECTED. THE PHYSICIAN REMOVED THE STYLET, OBTAINED A CORE SAMPLE AND WAS IN THE PROCESS OF REMOVING THE CUTTING CANNULA WHEN THE NEEDLE BROKE IN HALF. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) TO HAVE THE HALF THAT REMAINED IN THE BONE, REMOVED. THE ONCOLOGIST WENT INTO THE OR, AND PERFORMED THE NECESSARY BIOPSY PROCEDURE THROUGH THE OPEN INCISION. OTHER THAN HAVING TO HAVE THE NEEDLE REMOVED, THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL NOW. THE HALF OF THE CANNULA THAT WAS NOT LEFT IN THE BONE IS AVAILABLE FOR EVALUATION.