JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

Description of Event or Problem

THE FOLLOWING WAS REPORTED TO CARDINAL HEALTHCARE ON (B)(4) 2011: PHYSICIAN PERFORMING A BONE MARROW ASPIRATION. PHYSICIAN AND NURSE HEARD A POP. PHYSICIAN WITHDREW NEEDLE. TIP OF NEEDLE LOOKED SHORT. PHYSICIAN COMPARED THE NEEDLE TO ANOTHER OF THE SAME NEEDLE. TIP WAS MISSING FROM THE NEEDLE. NEEDLE TIP IS IN THE PATIENT EITHER BONE OR SOFT TISSUE. X-RAY INCLUSIVE. THEY ARE RE-EVALUATING THE X-RAY. PHYSICIAN FEELS THERE IS NO NEED FOR FURTHER INTERVENTION TO REMOVE TIP. PATIENT IS NOT IN PAIN BUT UNDERSTANDS WHAT HAPPENED. CUSTOMER WANTS THE NEEDLES IN THIS LOT EVALUATED. THEY DO NOT WANT THIS TO HAPPEN AGAIN. EXPIRATION DATE OF TRAY IS 11/2012. ON (B)(6) 2011, THE CUSTOMER ((B)(6)) AND SUPERVISOR OF QUALITY MANAGEMENT ((B)(6)) CONFIRMED THAT THERE WAS NO NEGATIVE PATIENT IMPACT. THE SAMPLE IS AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

(B)(4). EVALUATION OF THE COMPLAINT SAMPLE CONFIRMED THE TIPS OF BOTH THE BIOPSY NEEDLE (CANNULA) AND THE STYLET ARE BENT INWARDS. NO MATERIAL RUPTURE IS SHOWN ON THE SAMPLE. A THOROUGH INSPECTION OF THE TIP OF THE NEEDLE DID NOT IDENTIFY ANY QUALITY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE QUALITY PLAN INCLUDES INSPECTION POINTS FOR TIP GEOMETRY AND TIP DAMAGE. NO ISSUES WERE IDENTIFIED WITH THESE INSPECTIONS DURING THE MANUFACTURE OF LOT L1C165. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED CONDITION IS USE-RELATED. THE INVESTIGATION NOTED THE NEEDLE WAS EXCESSIVELY DEFORMED DUE TO A POTENTIAL EXCESSIVE FORCE BEING APPLIED TO THE NEEDLE. IT IS THE RECOMMENDATION OF THIS INVESTIGATION FOR THE USER OF THE DEVICE TO REVIEW LABELED INSTRUCTIONS AND PRECAUTIONARY WARNINGS RELATED TO EXCEEDING THE COMPRESSION STRESS LIMITS OF THIS DEVICE. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES.