SPROTTE® NRFIT

Additional Manufacturer Narrative

IRN#(B)(4). COMPLAINT TOOK PLACE IN GREAT BRITAIN. PLACEHOLDERS WERE INSERTED UNDER POINT H6, CODES B, C AND D, WHICH WERE NOT VERIFIED, AS THE INITIAL REPORT COULD ONLY BE PACKAGED IN THIS FORM IF THEY WERE FILLED IN. IN THIS FINAL REPORT, THESE PLACEHOLDERS FROM THE FIRST REPORT WERE CHANGED AFTER THE ROOT CAUSE ANALYSIS. THIS CONCERNS CODES B, C AND D. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT 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) INCIDENT OCCURRED IN GREAT BRITAIN: NEEDLE WAS USED ON A PATIENT BY AN ANAESTHETIST BUT WAS UNABLE TO INJECT DOWN THE NEEDLE. THE NEEDLE WAS REPOSITIONED THREE TIMES BUT HAD NO FLOW OF CSF WITH EACH ATTEMPT. THE NEEDLE WAS ASSUMED TO BE BLOCKED AND A NEW NEEDLE WAS USED FROM THE SAME BATCH. THE NEW NEEDLE HAD NO ISSUES.

Additional Manufacturer Narrative

IRN#: (B)(4). COMPLAINT TOOK PLACE IN (B)(6). UNDER ITEM H6, CODES B, C AND D, PLACEHOLDERS HAVE BEEN INSERTED THAT HAVE NOT BEEN VERIFIED, AS THE INTIAL REPORT CAN ONLY BE PACKED IN THIS FORM IF THESE ARE FILLED IN, ALTHOUGH NO ANALYSIS HAS YET TAKEN PLACE. THESE B, C AND D CODES CAN ONLY BE TRANSMITTED CORRECTLY IN THE SUBSEQUENT MESSAGE AS THE ANALYSIS IS STILL BEING PROCESSED. YOU WILL RECEIVE THE COMPLETE REPORT WITH ALL TEST RESULTS IN THE SUBSEQUENT MESSAGE.

Description of Event or Problem

IRN#: (B)(4). INCIDENT OCCURRED IN GREAT BRITAIN: NEEDLE WAS USED ON A PATIENT BY AN ANAESTHETIST BUT WAS UNABLE TO INJECT DOWN THE NEEDLE. THE NEEDLE WAS REPOSITIONED THREE TIMES BUT HAD NO FLOW OF CSF WITH EACH ATTEMPT. THE NEEDLE WAS ASSUMED TO BE BLOCKED AND A NEW NEEDLE WAS USED FROM THE SAME BATCH. THE NEW NEEDLE HAD NO ISSUES.