JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP

Description of Event or Problem

THE NEEDLE HAS BROKEN DURING THE PROCEDURE. A MEDICAL INTERVENTION HAS BEEN REPORTED TO EXTRACT THE REMAINING BIT OF THE NEEDLE FROM THE BONE. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

(B)(4). THE SAMPLE INVOLVED WAS RECEIVED FOR EVALUATION. EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. DURING SAMPLE EVALUATION, IT WAS NOTED THAT THE CANNULA WAS BROKEN; THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT THE MATERIAL USED FOR MANUFACTURE OF THE PRODUCT WAS UNRELATED TO THE REPORTED CONDITION AS RAW MATERIALS USED TO MANUFACTURE THE CANNULA NEEDLE PASSED ALL THE APPLICABLE QUALITY REQUIREMENTS. 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, PROCESSES OR MATERIALS TO THE REPORTED CONDITION.

Additional Manufacturer Narrative

(B)(4). AS A SAMPLE WAS NOT RECEIVED FOR EVALUATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. MANUFACTURING AND PACKAGING PROCESSES ARE IN PLACE THAT REQUIRES PERSONNEL TO PERFORM A VISUAL INSPECTION AND VERIFICATION OF A NEEDLE PRIOR TO THE NEEDLE PASSING TO THE NEXT STAGE. AN INSPECTION PROCESS IN PLACE ALSO REQUIRES FOR THE FUNCTIONAL CONDITION OF A NEEDLE TO BE VERIFIED AS WELL AS A VISUAL EXAMINATION OF THE NEEDLE ASSEMBLY PRIOR TO RELEASE OF THE PRODUCT. DURING REVIEW OF THE APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCESSES, NO ISSUES WERE FOUND THAT COULD RELATE PERSONNEL OR PROCESSES TO THE REPORTED CONDITION. IN ADDITION, IT IS NOT CONSIDERED THAT THE CONDITION OF THE MATERIAL COULD BE RELATED TO THE REPORTED CONDITION. THERE IS NO EVIDENCE THAT INSTRUCTIONS FOR USE (IFU) WERE NOT FOLLOWED PROPERLY; HOWEVER, THE DESCRIPTION PROVIDED BY THE CUSTOMER DID NOT MENTION THE ANGLE TO WHICH THE STEADY PRESSURE AND TWISTING MOTION WERE APPLIED. SPECIFIC SECTIONS OF THE IFU ARE OUTLINED FOR PROPER USE OF THE PRODUCT. IN ORDER TO PREVENT RECURRENCE, THE APPLICABLE PROCEDURE AT THE MANUFACTURING PLANT LEVEL WILL BE REVISED TO SPECIFICALLY INCLUDE INSPECTION FOR A BROKEN OR DAMAGED NEEDLE. THE MANUFACTURING PLANT PERSONNEL WILL ALSO BE MADE AWARE OF THIS REPORT TO HEIGHTEN AWARENESS.