SPROTTE® NRFIT (WITH INTRODUCER)

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. CORRECTION: IMDRF CODES: B15 TO B01; C19 TO C16 AND D14 TO D03. THE ERROR/CAUSE ANALYSIS WAS ALSO SUPPLEMENTED BY THE TEST RESULT OF THE SUBSEQUENTLY DELIVERED FAILURE SAMPLES (B)(6). 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 MONITORING THIS 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# (B)(4) DEVICE WAS BEING USED TO ADMINSTER SPINAL ANAESTHESIA FOR A EMERGENCY LOWER SEGMENT CAESAREAN SECTION. ANAESTHETIST WAS UNABLE TO INJECT THROUGH THE DEVICE AFTER FEELING LOSS OF RESISTANCE /GIVE. DEVICE WAS REMOVED. IT WAS NOTED THAT THE SPINAL NEEDLE DID NOT HAVE ANY HOLES AT THE TIP WHICH SHOULD HAVE HELPED TO INJECT THE MEDICATION.

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 MONITORING THIS 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# (B)(4). DEVICE WAS BEING USED TO ADMINISTER SPINAL ANAESTHESIA FOR A EMERGENCY LOWER SEGMENT CAESAREAN SECTION. ANAESTHETIST WAS UNABLE TO INJECT THROUGH THE DEVICE AFTER FEELING LOSS OF RESISTANCE /GIVE. DEVICE WAS REMOVED. IT WAS NOTED THAT THE SPINAL NEEDLE DID NOT HAVE ANY HOLES AT THE TIP WHICH SHOULD HAVE HELPED TO INJECT THE MEDICATION.

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. CORRECTION: IMDRF CODES: B15 TO B01; C19 TO C16 AND D19 TO D03. THE ERROR/CAUSE ANALYSIS WAS ALSO SUPPLEMENTED BY THE TEST RESULT OF THE SUBSEQUENTLY DELIVERED FAILURE SAMPLES (2024-08-26). 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# (B)(4). DEVICE WAS BEING USED TO ADMINISTER SPINAL ANAESTHESIA FOR AN EMERGENCY LOWER SEGMENT CAESAREAN SECTION. ANAESTHETIST WAS UNABLE TO INJECT THROUGH THE DEVICE AFTER FEELING LOSS OF RESISTANCE /GIVE. DEVICE WAS REMOVED. IT WAS NOTED THAT THE SPINAL NEEDLE DID NOT HAVE ANY HOLES AT THE TIP WHICH SHOULD HAVE HELPED TO INJECT THE MEDICATION.

Description of Event or Problem

IRN# (B)(4). DEVICE WAS BEING USED TO ADMINSTER SPINAL ANAESTHESIA FOR A EMERGENCY LOWER SEGMENT CAESAREAN SECTION. ANAESTHETIST WAS UNABLE TO INJECT THROUGH THE DEVICE AFTER FEELING LOSS OF RESISTANCE /GIVE. DEVICE WAS REMOVED. IT WAS NOTED THAT THE SPINAL NEEDLE DID NOT HAVE ANY HOLES AT THE TIP WHICH SHOULD HAVE HELPED TO INJECT THE MEDICATION.

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.