Tuohy 1150-6K091Recalls & reported problems
Pajunk GmbH Medizintechnologie · Tuohy with spec.Point,1cm grad. 18G x 3 1/2" (90mm), plastic stylet · 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 14048223004019), received between May 20, 2020 and Aug 6, 2020 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Break1
- Loss of or Failure to Bond1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Break; Break
IRN#: (B)(4). BROKEN HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10374695 ↗MalfunctionMay 20, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IRN#: (B)(4). TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: WHEN THE CANNULA WAS REMOVED, THE COMPLETE HUB CAME OFF. THE CANNULA TUBE HAD TO BE REMOVED WITH A NEEDLE HOLDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10073554 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.