EpiSpin Safety NRFit 1022461-30Recalls & reported problems
Pajunk GmbH Medizintechnologie · EpiSpin Safety NRFit Tuohy NRFit 18G x 90mm with back eye and wings · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223074800), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fitting Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Break; Fitting Problem
IRN# (b)(4)This incident took place in France (Polynésie).An epidural catheter was to be inserted in case additional anesthetic dosingbecame necessary and to provide postoperative epidural analgesia.After completion of the spinal anesthesia, an attempt was made to withdraw the spinal needle (Sprotte) from the epiduralneedle (Tuohy). The metallic portion of the spinal needle remained lodged inside the epidural needle while both werestill in the patient's back, with no possibility of grasping it. The plastic hub of the spinal needle, to which the injectionsyringe is attached and locked, detached and fell to the floor.As there was no longer any external access point to the metallic portion of the spinal needle, it became necessary toremove the epidural needle in order to safely withdraw the spinal needle from the patient's back.Consequently, it was no longer possible to use the epidural needle to thread an epidural catheter and administeradditional anesthetic doses should the surgical procedure be prolonged, nor to provide postoperative epidural analgesia.)
Patient problems: Foreign Body In Patient
MAUDE report 50913372 ↗
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- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
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- BD Glaspak 405675Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
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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