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SPROTTE® 001151-30ARecalls & reported problems

Pajunk GmbH Medizintechnologie · SPROTTE® 24G x 3 1/2" (90mm), sterile · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223000035), received between Feb 21, 2018 and Oct 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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.

Most reported problems

Device problems

  • Device Handling Problem1
  • Fracture1
  • Material Separation1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Foreign Body In Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 2, 2019Material Separation; Material Separation

    (B)(4). INITIAL REPORTER´S NARRATIVE: NEEDLE PULLED OUT OF THE HUB.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9143777 ↗
  • MalfunctionFeb 21, 2018Fracture; Device Handling Problem; Fracture; Device Handling Problem

    (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTERS NARRATIVE: SPROTTE BREAKS UPON REMOVAL THROUGH INTRODUCER.

    Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7284986 ↗

Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices

All NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.