JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP

Additional Manufacturer Narrative

(B)(4). ONE SAMPLE WAS RECEIVED. DURING SAMPLE VISUAL INSPECTION IT WAS NOTICED THAT THE CANNULA NEEDLE WAS COMPLETELY DETACHED AND THE FAILURE MODE WAS CONFIRMED. THERE WERE NO ISSUES FOUND DURING THE APPLICABLE MANUFACTURING PROCESS THAT CAN RELATE PERSONNEL WITH THE REPORTED FAILURE MODE. IT IS CONSIDERED MATERIAL COULD BE RELATED TO FAILURE MODE REPORTED. HOWEVER, COMPONENT THAT PRESENTS THE FAILURE IS FROM A SUPPLIER AND IS NOT ALTERED BY THE CAREFUSION (B)(4) MANUFACTURING FACILITY PRIOR TO FINAL ASSEMBLY. THE SUPPLIER HAS BEEN CONTACTED REGARDING THIS ISSUE

Description of Event or Problem

VIA EMAIL IT WAS REPORTED THAT THE NEEDLE BROKE APART FROM THE COMPONENT THAT PULLS IT IN AND OUT. IT WAS STUCK IN THE PATIENT AND THE NURSE HAD TO USE OTHER RESOURCES TO GRAB THE NEEDLE AND PULL IT OUT OF THE PATIENT. ANOTHER ONE FROM SAME LOT NUMBER WAS USED WHEN THIS ONE DIDN¿T WORK, AND THAT OTHER ONE WORKED FINE. THERE WAS NO INJURY INVOLVED. ON (B)(6) 2014, THE CUSTOMER ((B)(6)) PROVIDED THE FOLLOWING INFORMATION AS RECEIVED FROM THE END USER: THE BONE BEING BIOPSIED WAS THE POSTERIOR ILIAC CREST. THERE WAS NOTHING NOTED OF THE NEEDLE PRIOR TO PATIENT USE THAT WOULD INDICATE A DEFECT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY WHEN INSERTING THE NEEDLE INTO THE PATIENT. THE ISSUE OCCURRED DURING THE FIRST BIOPSY ATTEMPT. THE IMPACT TO THE PATIENT WAS THE NEED FOR REPEAT ATTEMPT AT BIOPSY SO MAY HAVE HAD INCREASED PAIN AT SITE BUT LIKELY MINIMAL IF ANY. THE PATIENT'S CURRENT STATUS IS: NO ISSUES RELATED TO BIOPSY.

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: ONE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE CANNULA NEEDLE WAS COMPLETELY DETACHED. 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. PROCEDURES REQUIRE VERIFICATION OF THE CONDITION OF THE ASSEMBLED NEEDLE AND FUNCTIONALITY PRIOR TO RELEASING THE PRODUCT. IN ADDITION, 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. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE MOST PROBABLE ROOT CAUSE COULD BE RELATED TO MATERIAL PROVIDED FROM THE SUPPLIER. AS A RESULT, A FORMAL SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN ISSUED TO THE SUPPLIER TO ADDRESS THE REPORTED ISSUE. IN ADDITION, THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.