ICP LUER ADAPTOR

Additional Manufacturer Narrative

(B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative

TWO ICP LUER ADAPTORS P/N 16-1057; LOT # 464837 WERE RETURNED TO CODMAN FOR EVALUATION. AS RECEIVED AND AFTER ETO DECONTAMINATION, IT WAS VERIFIED THAT BOTH ICP LUER ADAPTORS WERE CRACKED ON THE LUER ADAPTOR SIDE. ONE OF THE ADAPTORS HAS ONE CRACK AND THE SECOND ONE HAS TWO CRACKS. THE CAUSE(S) OF THE DAMAGES COULD NOT BE FULLY DETERMINED. IT APPEARS THAT BOTH ADAPTORS WERE OVER-TIGHTENED WITH THE COUNTERPART PRODUCT(S); HOWEVER, IT COULD NOT BE CONFIRMED. A LOT HISTORY RECORDS REVIEW FOR P/N 16-1057; LOT # 464837 WAS CONDUCTED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON JANUARY 16, 2014. A COMPLAINTS RECORDS REVIEW WAS ALSO CONDUCTED AND IT WAS VERIFIED THAT THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT DURING THE LAST FIVE YEARS AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

Description of Event or Problem

THE AFFILIATE REPORTED "PLACEMENT OF A EXTERNAL VENTRICULAR DRAINAGE CATHETER 821745 AND CONNECTION TO A 821731 DRAINAGE COLLECTION SYSTEM BY MEANS OF A 16-1057 CONNECTOR 1079 PROCEDURE/SURGERY DATE (B)(6) 2014 (B)(4) -DESCRIBE EVENT ON (B)(6) 2014, DOCTOR INFORMED ME OF A LEAKAGE PROBLEM OCCURRING AT THE CONNECTOR BETWEEN THE BACTISEAL EVD CATHETER 82-1745 AND THE CODMAN REFERENCE 821731 EXTERNAL DRAINAGE SYSTEM EDS3. THE CONNECTOR = CODMAN ITEM 16-1057. DUE TO BLOOD IN THE 821731, A NEW 821731 HAD TO BE COUPLED TO THE 821745 AND EVEN THOUGH THE 821731 WAS CONNECTED VERY CAREFULLY TO THE 161057, THE DOCTOR HEARD A KIND OF ?CLACK? NOISE AND SHE COULD SEE A CRACK IN THE FEMALE LUER LOCK CONNECTOR PART. TRYING WITH ANOTHER 161057 WITH THE SAME LOT NUMBER, JUST THE SAME PROBLEM HAPPENED AGAIN SO A THIRD CONNECTOR HAD TO BE CONNECTED AND THEN FINALLY THE CONNECTION WAS OK. WHEN I WAS PROVIDED WITH THE PRODUCTS, I COULD SEE A LITTLE CRACK AT THE FEMALE LUER LOCK PART OF BOTH RETURNED CONNECTORS."