SPROTTE®
Received Dec 23, 2025 · Event occurred Dec 15, 2025
Report 9611612-2025-00051 · MDR key 23876578
Device
Generic name
Sprotte®
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
321151-31A
Lot number
1569
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). INVESTIGATIONS ARE ONGOING. FINAL EVALUATION CAN BE FOUND IN THE FOLLOWING REPORT.
Description of Event or Problem
(B)(4). INCIDENT OCCURRED IN GERMANY. TENTATIVE TRANSLATION: IT WAS NOT THE CANNULA BUT THE INTRODUCER THAT SLIPPED OUT OF THE CONNECTOR AFTER USE - THE ADHESIVE HAD COME LOOSE. THE END OF THE INTRODUCER WAS STILL PROTRUDING FROM THE PATIENT, SO THE CANNULA COULD BE REMOVED WITH TWEEZERS. NO FURTHER TREATMENT WAS NECESSARY - THE PATIENT IS DOING WELL.
Additional Manufacturer Narrative
IRN# (B)(4). 2026-01-30 UPDATE: DEVICE WAS EVALUATED AND THE IMDRF CODES ADJUSTED. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.
Description of Event or Problem
IRN# (B)(4). INCIDENT OCCURRED IN GERMANY. TENTITIVE TRANSLATION: IT WAS NOT THE CANNULA BUT THE INTRODUCER THAT SLIPPED OUT OF THE CONNECTOR AFTER USE - THE ADHESIVE HAD COME LOOSE. THE END OF THE INTRODUCER WAS STILL PROTRUDING FROM THE PATIENT, SO THE CANNULA COULD BE REMOVED WITH TWEEZERS. NO FURTHER TREATMENT WAS NECESSARY - THE PATIENT IS DOING WELL.