SPROTTE® NRFIT (WITH INTRODUCER)
Received Jul 5, 2024 · Event occurred May 25, 2024
Report 9611612-2024-00004 · MDR key 19678670
Device
Generic name
Spinal Needle, Single-use
Manufacturer
Pajunk Gmbh MedizintechnologieModel number
AA010287Catalog number
021163-29A
Lot number
1519
Product problems
- Nonstandard Device
- No Flow
- Nonstandard Device
- No Flow
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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# (B)(4). PATIENT ATTENDED MATERNITY THEATRES FOR AN ELECTIVE LSCS UNDER SPINAL ANAESTHESIA. DURING ATTEMPTS AT INSERTING A SPINAL NEEDLE NO CSF WAS FREELY DRAINING FROM THE SPINAL NEEDLE AT WHICH POINT A DIFFERENT OPERATOR USED A NEW NEEDLE AND WAS ABLE TO GIVE A SPINAL ANAESTHETIC. THE CASE PROCEEDED FOLLOWING THIS. UPON INSPECTION OF THE ORIGINAL NEEDLE THERE APPEARED TO BE NO APERTURE ON THE SIDE OF THE NEEDLE TO ALLOW PASSAGE OF CSF OR INJECTION OF INTRATHECAL MEDICATION. IT WAS NOT POSSIBLE TO INJECT ANY SALINE THROUGH THE NEEDLE UPON INSPECTION OF THE NEEDLE IN THE ANAESTHETIC ROOM.
Description of Event or Problem
IRN (B)(4) PATIENT ATTENDED MATERNITY THEATRES FOR AN ELECTIVE LSCS UNDER SPINAL ANAESTHESIA. DURING ATTEMPTS AT INSERTING A SPINAL NEEDLE NO CSF WAS FREELY DRAINING FROM THE SPINAL NEEDLE AT WHICH POINT A DIFFERENT OPERATOR USED A NEW NEEDLE AND WAS ABLE TO GIVE A SPINAL ANAESTHETIC. THE CASE PROCEEDED FOLLOWING THIS. UPON INSPECTION OF THE ORIGINAL NEEDLE THERE APPEARED TO BE NO APERTURE ON THE SIDE OF THE NEEDLE TO ALLOW PASSAGE OF CSF OR INJECTION OF INTRATHECAL MEDICATION. IT WAS NOT POSSIBLE TO INJECT ANY SALINE THROUGH THE NEEDLE UPON INSPECTION OF THE NEEDLE IN THE ANAESTHETIC ROOM.
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.
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# (B)(4). PATIENT ATTENDED MATERNITY THEATRES FOR AN ELECTIVE LSCS UNDER SPINAL ANAESTHESIA. DURING ATTEMPTS AT INSERTING A SPINAL NEEDLE NO CSF WAS FREELY DRAINING FROM THE SPINAL NEEDLE AT WHICH POINT A DIFFERENT OPERATOR USED A NEW NEEDLE AND WAS ABLE TO GIVE A SPINAL ANAESTHETIC. THE CASE PROCEEDED FOLLOWING THIS. UPON INSPECTION OF THE ORIGINAL NEEDLE THERE APPEARED TO BE NO APERTURE ON THE SIDE OF THE NEEDLE TO ALLOW PASSAGE OF CSF OR INJECTION OF INTRATHECAL MEDICATION. IT WAS NOT POSSIBLE TO INJECT ANY SALINE THROUGH THE NEEDLE UPON INSPECTION OF THE NEEDLE IN THE ANAESTHETIC ROOM.