EPILONG NRFIT®

Additional Manufacturer Narrative

EVENT TOOK PLACE IN UK. THE FACTS OF THE CASE, RELEVANT TESTS ARE CURRENTLY IN PROCESS. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

IRN (B)(4). THE EPIDURAL CATHETER EASILY DETACHES FROM THE 'SECURE' ATTACHMENT TO THE FILTER. ONE DETACHED WHEN IN-SITU. THIS IS A POTENTIAL EPIDURAL SPACE CONTAMINATION CONCERN. THE DEVICE IS NOT FIT FOR PURPOSE. I'VE OPENED SEVERAL BOXES AND ALL ARE EQUALLY INSECURELY ATTACHED. REMEDIAL ACTIONS TAKEN BY HEALTHCARE FACILITY, PATIENT, OR USER SUBSEQUENT TO THE INCIDENT: I SPENT A WHILE SEEING IF I COULD GET THE 'CLAMPING ADAPTOR' TO SECURELY HOLD THE CATHETER, HOWEVER THE CATHETER WAS ALWAYS EASILY PULLED OUT. WE HAVE REMOVED THIS KIT FROM OUR PRACTICE ON DELIVERY SUITE.

Additional Manufacturer Narrative

EVENT TOOK PLACE IN UK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORING THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY. THIS PRODUCT ANALYSIS WAS CARRIED OUT ON THE BASIS OF ALL THE INFORMATION PROVIDED AND THE INTERNAL REVIEW AT PAJUNK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORINGTHIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

IRN# 223-24_895. THE EPIDURAL CATHETER EASILY DETACHES FROM THE 'SECURE' ATTACHMENT TO THE FILTER. ONE DETACHED WHEN IN-SITU. THIS IS A POTENTIAL EPIDURAL SPACE CONTAMINATION CONCERN. THE DEVICE IS NOT FIT FOR PURPOSE. I'VE OPENED SEVERAL BOXES AND ALL ARE EQUALLY INSECURELY ATTACHED. REMEDIAL ACTIONS TAKEN BY HEALTHCARE FACILITY, PATIENT, OR USER SUBSEQUENT TO THE INCIDENT: I SPENT A WHILE SEEING IF I COULD GET THE 'CLAMPING ADAPTOR' TO SECURELY HOLD THE CATHETER, HOWEVER THE CATHETER WAS ALWAYS EASILY PULLED OUT. WE HAVE REMOVED THIS KIT FROM OUR PRACTICE ON DELIVERY SUITE.