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SPROTTE® 501151-29ARecalls & reported problems

Pajunk GmbH Medizintechnologie · SPROTTE® 25G 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 14048223000844), received between Feb 26, 2018 and Nov 7, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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

  • Failure To Adhere Or Bond1
  • Fracture1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 7, 2018Fracture; Fracture

    IRN# (B)(4). SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA GOT LOOSENED FROM HUB.

    Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

    MAUDE report 8045399 ↗
  • MalfunctionFeb 26, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

    (B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: UPON REMOVAL OF THE SPINAL NEEDLE THE HUB CAME OFF THE NEEDLE.

    Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

    MAUDE report 7295479 ↗

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.