AFFILIATE REPORTED THAT: "LEAKAGE PROBLEM OCCURRING AT THE CONNECTOR BETWEEN THE BACTISEAL EVD CATHETER 82-1745 AND THE CODMAN REFERENCE 82-1731 EXTERNAL DRAINAGE SYSTEM EDS3. THE CONNECTOR = CODMAN ITEM 16-1057. DUE TO BLOOD IN THE 82-1731, A NEW 82-1731 HAD TO BE COUPLED TO THE 82-1745 AND EVEN THOUGH THE 82-1731 WAS CONNECTED VERY CAREFULLY TO THE 16-1057, THE DOCTOR HEARD A KIND OF ?CLACK? NOISE AND SHE COULD SEE A CRACK IN THE FEMALE LUER LOCK CONNECTOR PART. THIS IS EXACTLY THE SAME COMPLAINT AS (B)(4): SAME HOSPITAL, DIFFERENT DOCTOR. THE SAMPLE FOR THIS SECOND COMPLAINT WAS UNFORTUNATELY DISCARDED. BOTH DOCTORS TAKE THESE COMPLAINTS VERY SERIOUSLY BECAUSE THE EXTRA HANDLINGS INVOLVED IN SOLVING THIS PROBLEM EXPOSED THE PATIENT TO ADDITIONAL HIGH RISKS. FOR EXAMPLE, THERE IS THE POSSIBILITY THAT THE PATIENT GETS AN INFECTION OF THE MENINGES. OUR PRODUCT SPECIALIST EMPHASIZED THAT THE HOSPITAL IS REQUESTING A DETAILED ANALYSIS OF THESE EVENTS, BECAUSE OF THE POSSIBLE HIGH RISKS INVOLVED".
N
Patient 1
(B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT, THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.
N
Patient 1
COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. IN THE ABSENCE OF THE COMPLAINT SAMPLE, A LOT HISTORY RECORDS REVIEW FOR P/N 16-1057; LOT # 118703, WAS CONDUCTED AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT # 118703 WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED FROM MANUFACTURING ON JULY 28, 2011. A COMPLAINT RECORDS REVIEW WAS ALSO CONDUCTED, AND IT WAS VERIFIED THAT DURING THE LAST FIVE YEARS THIS IS THE FIRST COMPLAINT REPORTED FOR THIS TYPE OF ISSUE, FOR THIS PRODUCT CODE AND LOT NUMBER, AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.