ILLINOIS NEEDLE BONE MARROW 18G ADJ LEN

Description of Event or Problem

(B)(6) APPEARED BY AMBULANCE TO (B)(6) HOSPITAL. THE NEWBORN HAD TROUBLE IN HIS/HER LEFT VENTRICLE OF THE HEART, AND CYANOSIS WAS PRODUCED AFTER SEVERE VENTRICULAR FIBRILLATION(VF).  ONE ILLINOIS BONE MARROW BIOPSY NEEDLE WAS PLACED IN HIS/HER LEFT TIBIA, BUT LEAKED FLUID WAS CONFIRMED FROM THE HUB PART OF THE NEEDLE.  OTHER NEEDLE UNDER THE SAME LOT WAS PLACED IN RIGHT TIBIA AND SECURED AN EMERGENCY VASCULAR ACCESS, BUT THE PATIENT WAS CONFIRMED DEAD. ON (B)(6) 2012, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE INTERNATIONAL CONTACT ((B)(6)): CAUSAL CONNECTION:  UNKNOWN.  FOR THE FIRST BIOPSY NEEDLE A CAUSAL LINKAGE BETWEEN THE LEAKED FLUID AND THE PATIENT DEATH COULD NOT BE CONFIRMED.  DR (B)(6) WHO PERFORMED THE PROCEDURE, MENTIONED HAVING NO INTENTION TO MAKE A CONNECTION BETWEEN THE PATIENT DEATH AND THE PRODUCT DEFECT. CAUSE OF DEATH: UNKNOWN.  DETAILS WERE NOT CONFIRMED.  THE DISTRIBUTOR ((B)(4)) INFORMED THE INTERNATIONAL CONTACT THAT THE PATIENT PROBABLY HAD A CARDIAC ARREST AND WAS TAKEN TO THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

(B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION. A LEAK TEST WAS PERFORMED WITH A SIMULATED TISSUE AND NO LEAK ISSUES WERE IDENTIFIED. TO PERFORM THE LEAK, A NEW SYRINGE WAS UTILIZED AS THE ACTUAL SYRINGE USED IN THE PROCEDURE WAS NOT RECEIVED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE HISTORY RECORD FOR THE LOT REPORTED DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. DURING A REVIEW OF THE MANUFACTURING PROCESS, NO ISSUES WERE IDENTIFIED THAT COULD RELATE PERSONNEL TO THE REPORTED CONDITION. THE MANUFACTURING AND PACKAGING PROCESSES ARE CLEARLY DEFINED. REGARDING VERIFICATION OF THE REPORTED FAILURE DURING QUALITY INSPECTION, THE APPLICABLE PROCEDURE REQUIRES THAT SEVERAL VISUAL AND FUNCTIONAL TESTS BE PERFORMED PRIOR TO RELEASING THE PRODUCT; HOWEVER, NO LEAK TEST IS PERFORMED. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS THE SAMPLE RECEIVED DID NOT PRESENT ISSUES DURING THE LEAK TEST PERFORMED. THE NEEDLE FUNCTIONED AS EXPECTED AND THE CONDITION OF THE SAMPLE'S MATERIAL WAS NOTED TO BE IN PROPER CONDITION. ALTHOUGH THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE PROBABLE ROOT CAUSE FOR THIS PARTICULAR INCIDENT COULD NOT BE DETERMINED, THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE FOR REQUIRED CORRECTIVE ACTIONS.