SPROTTE®
Received Apr 23, 2025 · Event occurred Mar 20, 2025
Report 9611612-2025-00010 · MDR key 21887853
Device
Generic name
Sprotte®_needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Pajunk Gmbh MedizintechnologieModel number
511151-29ACatalog number
511151-29A
Lot number
1527
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IRN# (B)(4). COMPLAINT TOOK PLACE IN SWEDEN. THIS INCIDENT DID NOT TAKE PLACE IN THE USA, BUT AS CO-REPORTED. 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 SWEDEN: THE NEEDLE CAME OFF/DISCONNECTED FROM THE CANNULA HOLDER, SEE ATTACHED PICTURE. THE NEEDLE REMAINED IN THE PATIENT, BARELY 1 CM OF THE NEEDLE WAS VISIBLE AT THAT TIME.