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SPROTTE® 511151-29A (UDI 14048223001605)Recalls & reported problems

Pajunk GmbH Medizintechnologie · SPROTTE® effect 25G x 3 1/2" (90mm), sterile with Introducer · 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 14048223001605), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1
  • Loss of or Failure to Bond1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 2, 2019Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

    (B)(4). INITIAL REPORTER´S NARRATIVE: RECENTLY WE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS THAT A SPROTTE NEEDLE SNAPPED FROM THE HUB WHILE BEING USED IN SURGERY. THE STAFF MEMBER THAT ENCOUNTERED THIS INCIDENT HAS REPORTED THIS ISSUE TO THE TGA AND IS VERY UNHAPPY WITH THE SITUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9143774 ↗

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.