SPROTTE® 2.G 141251-27ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 4" (103mm) with Introducer,sterile · Class 2
All models of SPROTTE 2.G (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14048223022815), received between Nov 7, 2017 and Feb 7, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak3
- Break2
- Crack2
- Manufacturing, Packaging or Shipping Problem2
- Product Quality Problem2
- Leak/Splash1
Patient problems
- Inadequate Pain Relief2
- No Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
(B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTERS NARRATIVE: LEAKAGE AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246913 ↗MalfunctionNov 7, 2017Break; Crack; Fluid/Blood Leak; Leak/Splash; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Break; Crack; Fluid/Blood Leak; Leak/Splash; Product Quality Problem; Manufacturing, Packaging or Shipping Problem
(B)(4). FROM INITIAL REPORTERS NARRATIVE: LEAKAGE AT THE HUB.
Patient problems: Inadequate Pain Relief; No Information
MAUDE report 7005453 ↗MalfunctionNov 7, 2017Break; Crack; Fluid/Blood Leak; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Break; Crack; Fluid/Blood Leak; Product Quality Problem; Manufacturing, Packaging or Shipping Problem
IRN# (B)(4). FROM INITIAL REPORTERS NARRATIVE: AT THE ASPIRATION OF THE LCR LIQUID, THERE IS AIR INSIDE THE SYRINGE. AT THE INJECTION, LEAKAGE AT THE HUB. THIS EVENT OCCURS AT 2 TIME AT 3.
Patient problems: Inadequate Pain Relief; No Information
MAUDE report 7005452 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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