SPROTTE® NRFIT

Description of Event or Problem

(B)(4). INCIDENT OCCURRED IN GREAT BRITAIN: SPINAL NEEDLE BEING USED IN DELIVERY SUITE FOR LABOURING PATIENT. ON WITHDRAWING THE INTRODUCER IT GOT STUCK IN THE NEEDLE SO THE ENTIRE NEEDLE AND INTRODUCER REMOVED AND A FRESH ONE USED. A NEW NEEDLE USED - PATIENT UNNECESSARILY HAD TWO SPINAL NEEDLE PASSES. ON EXAMINING THE FAULTY NEEDLE, THERE APPEARS TO BE EXCESS FRICTION BETWEEN THE SPINAL NEEDLE AND THE INTRODUCER IMPLYING THAT THE SPINAL NEEDLE HAS A NARROWING. THE INTRODUCED COULD BE REMOVED (OUTSIDE OF THE PATIENT) BUT THEN THE SPINAL NEEDLE COULD NOT BE FLUSHED WITH SALINE EASILY.

Additional Manufacturer Narrative

(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.

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 (B)(6): SPINAL NEEDLE BEING USED IN DELIVERY SUITE FOR LABOURING PATIENT. ON WITHDRAWING THE INTRODUCER IT GOT STUCK IN THE NEEDLE SO THE ENTIRE NEEDLE AND INTRODUCER REMOVED AND A FRESH ONE USED. A NEW NEEDLE USED - PATIENT UNNECESSARILY HAD TWO SPINAL NEEDLE PASSES. ON EXAMINING THE FAULTY NEEDLE, THERE APPEARS TO BE EXCESS FRICTION BETWEEN THE SPINAL NEEDLE AND THE INTRODUCER IMPLYING THAT THE SPINAL NEEDLE HAS A NARROWING. THE INTRODUCED COULD BE REMOVED (OUTSIDE OF THE PATIENT) BUT THEN THE SPINAL NEEDLE COULD NOT BE FLUSHED WITH SALINE EASILY.