inforMED
MalfunctionBSP

SPROTTE®

Received Feb 4, 2025 · Event occurred Jan 24, 2025

Report 9611612-2025-00001 · MDR key 21303033

Device

Generic name

Sprotte® _needle, Conduction, Anesthetic (w/wo Introducer)

Model number

121151-27A

Catalog number

121151-27A

Lot number

1543

Product problems

  • Break
  • Break

Patient

NA · Female

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions
  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IRN#(B)(4) INCIDENT OCCURRED IN GERMANY: ORIGINAL TEXT GERMAN: PUNKTION LEGE ARTIS, DABEI BRUCH DER NADEL DIREKT HINTER DER FÜHRUNGSKANÜLE. ZU KEINER ZEIT ERHÖHTER KRAFTAUFWAND, NADEL NACH ENTFERNUNG DURCH CHIRURG NICHT VERFORMT. TRANSLATED INTO ENGLISH: PUNCTURE LEGE ARTIS, NEEDLE BREAKAGE DIRECTLY BEHIND THE GUIDE CANNULA. NO INCREASED FORCE REQUIRED AT ANY TIME, NEEDLE NOT DEFORMED AFTER REMOVAL BY SURGEON.

Additional Manufacturer Narrative

IRN# (B)(4) COMPLAINT TOOK PLACE IN GERMANY. THE NECESSARY PLACEHOLDERS FOR PACKING THE INITIAL REPORT BY THE SUBMITTER IN H6, CODE B, C AND D CAN STILL CHANGE IN THE FINAL REPORT. THE REPORTED INCIDENT IS CURRENTLY STILL BEING PROCESSED. THE TEST RESULTS WILL BE PROVIDED IN THE FOLLOWING REPORT.

Additional Manufacturer Narrative

(B)(4). COMPLAINT TOOK PLACE IN GERMANY. THE NECESSARY PLACEHOLDERS FOR PACKING THE INITIAL REPORT BY THE ESUBMITTER IN H6, CODE B, C AND D CAN STILL CHANGE IN THE FINAL REPORT. CHANGES IN THESE FU1 DOCUMENT UNDER H6 COMPARED TO THE INITIAL MESSAGE. B-CODE: 10. C-CODE: 4243. D-CODE: REMAINS AS IN INITIAL MESSAGE. E-CODE: 2687. F-CODE: 4625. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS CASE 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

(B)(4). INCIDENT OCCURRED IN GERMANY: ORIGINAL TEXT GERMAN: PUNKTION LEGE ARTIS, DABEI BRUCH DER NADEL DIREKT HINTER DER FÜHRUNGSKANÜLE. ZU KEINER ZEIT ERHÖHTER KRAFTAUFWAND, NADEL NACH ENTFERNUNG DURCH CHIRURG NICHT VERFORMT. TRANSLATED INTO ENGLISH: PUNCTURE LEGE ARTIS, NEEDLE BREAKAGE DIRECTLY BEHIND THE GUIDE CANNULA. NO INCREASED FORCE REQUIRED AT ANY TIME, NEEDLE NOT DEFORMED AFTER REMOVAL BY SURGEON.