JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

Additional Manufacturer Narrative

(B)(4) CAREFUSION INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 0001062525. NO ISSUES WERE FOUND, INDICATING THAT MANUFACTURING PROCEDURES WERE PROPERLY FOLLOWED, AND SUBSEQUENT QUALITY INSPECTIONS WERE PASSED. A FAILURE COULD NOT BE CONFIRMED AS NO SAMPLE WAS AVAILABLE FOR ANALYSIS. THE DEVICE HISTORY RECORD INDICATED THAT THE JAMSHIDI BONE MARROW TRAY WAS BUILT ACCORDING TO PROCEDURE, AND QUALITY INSPECTIONS FOR THE DEVICE WERE PASSED. THEREFORE, A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE LACK OF A DEFINITIVE ROOT CAUSE, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE IDENTIFIED FOR THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE ADDED TO THE COMPLAINT TRENDING SYSTEM AND WILL BE MONITORED FOR FUTURE OCCURRENCES.

Additional Manufacturer Narrative

(B)(4). A FOLLOW UP EMDR WILL BE SUBMITTED UPON CAREFUSION'S INVESTIGATION. (B)(4).

Description of Event or Problem

WHILE DOING CORE ASPIRATION, (IT WAS REPORTED) THE NEEDLE BROKE OFF IN THE PATIENT'S ILIAC CREST, REQUIRING HER TO GO TO THE HOSPITAL FOR (SURGICAL CONSULT) FOR (POSSIBLE) REMOVAL OF THE NEEDLE. ADDITIONAL INFORMATION RECEIVED; HOSPITAL STATED THEY DID NOT SEE THE NEEDLE AFTER MRI WAS PERFORMED AND NOTHING WAS SEEN. PHYSICIAN REPORTED THERE WAS NO DIFFICULTY ENTERING THE ILIAC CREST. NO FURTHER INTERVENTION NEEDED AT THIS POINT. PROCEDURE WAS NOT REPEATED.