Quincke NRFit 1163-3E090Recalls & reported problems
Pajunk GmbH Medizintechnologie · Quincke NRFit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 14048223029357), received between Oct 24, 2019 and Oct 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- No Consequences Or Impact 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 24, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: CER: PERFORMED A SPINAL INJECTION AND ON THE REMOVAL OF THE NEEDLE FROM THE PATIENT THE NEEDLE HUB CAME AWAY FROM THE NEEDLE ITS SELF. THIS WAS A STRAIGHTFORWARD PROCEDURE, STEPHEN BROWN WAS ABLE TO REMOVE THE METAL PART OF THE NEEDLE AS HE HAD ONE HAND ON THE PLASTIC HUB OF THE NEEDLE AND ONE ON THE METAL PART OF THE NEEDLE, BECAUSE OF THIS NONE OF THE NEEDLE WAS LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9231208 ↗
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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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