SPROTTE® NRFIT® (WITH INTRODUCER)
Received Nov 26, 2024 · Event occurred Nov 14, 2024
Report 9611612-2024-00029 · MDR key 20785478
Device
Generic name
Sprotte® Nrfit®_needle Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Pajunk Gmbh MedizintechnologieModel number
021163-29ACatalog number
021163-29A
Lot number
1396
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IRN# (B)(4). COMPLAINT TOOK PLACE IN UNITED KINGDOM. IN THE PROCESS OF ADMINISTERING SINGLE SHOT SPINAL ANAESTHESIA ON TWO OCCASSIONS (SAME PATIENT) THE DR BENT THE SPROTTE (PHOTO ATTACHED). WHEN DESCRIBED HE WAS REASONABLY SURE HE HAD NOT HIT BONE, THOUGH I AM NOT SO SURE. HE SUCCESSFULLY USED ANOTHER NEEDLE TO COMPLETE AND THEN FOR THE FOLLOWING CASE WITHOUT INCIDENT.
Additional Manufacturer Narrative
IRN# (B)(4). COMPLAINT TOOK PLACE IN UNITED KINGDOM. THIS IS A COMPLETE REPORT WITH ALL THE INFORMATION AND TEST RESULTS THAT WERE AVAILABLE AT THE GIVEN TIME. THE FAILURE SAMPLE WAS NOT SENT TO PAJUNK FOR TESTING - A PICTURE WAS SEND. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.