CATHY-CLOSED S.CH12 45CM/78

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THE "HOSPITAL IS CONCERNED WITH INFECTION." ADDITIONAL EVENT INFORMATION WAS PROVIDED VIA EMAIL ON (B)(4) 2014 INFORMING THAT THEY REPLACED THE DEVICE DUE TO THE CONTINUED ISSUES WITH SLEEVE INFLATION AND MOISTURE BUILD-UP. NO INFORMATION WAS PROVIDED OR REPORTED THAT ANY INFECTIONS HAD OCCURRED TO PATIENT(S); THEY FURTHER INFORMED THAT THEY CANNOT DETERMINE EXACT NUMBER OF PATIENT(S) INVOLVED AND THE PRODUCT WAS USED IN THE SURGICAL INTENSIVE CARE UNIT. THEY WENT ON TO INFORM THAT IT IS UNKNOWN HOW LONG THE PRODUCT WAS IN USE PRIOR TO THE EVENT OCCURRING. ISSUES OCCURRED ON FIVE (5) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (4) CASES UNDER PATIENT IDENTIFIER(S) (B)(4). MFR REPORTS #: 3007966929-2014-00017, 00019, 00021 AND 00023 RESPECTIVELY. (REPORT 5 OF 5) NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

Description of Event or Problem

IT WAS REPORTED "INFLATION OF CATHETER SLEEVE (MAKING IT DIFFICULT TO MANIPULATE THE CATHETER DUE TO THE AIR PRESSURE); MOISTURE BUILD-UP INSIDE THE SLEEVE." NOTE: THIS REPORTED ISSUE OCCURRED ON FIVE SEPARATE CASES.