SPROTTE® 121151-27A (UDI 04048223107096)Recalls & reported problems
Pajunk GmbH Medizintechnologie · Distal Tip: SPROTTE® Proximal End: ISO 80369-7 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223107096), received between Feb 4, 2025 and Feb 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Break; Break
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.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21303033 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.