EPISPIN II 0021351-18Recalls & reported problems
Pajunk GmbH Medizintechnologie · 0021351-18 · 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 04048223103647), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem1
Patient problems
- Abrasion1
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2024Fail-Safe Problem; Fail-Safe Problem
IRN# (B)(4). AVANT L'UTILISATION DU TROCART DE PÉRIDURALE SUR LE PATIENT, LE MÉDECIN SE PIQUE AVEC L'AIGUILLE. IL SEMBLERAIT QUE LA PROTECTION SOIT TROP COURTE : L'AIGUILLE EST NON PROTÉGÉE. BEFORE USING THE EPIDURAL TROCAR ON THE PATIENT, THE DOCTOR PRICKS HIMSELF WITH THE NEEDLE. IT SEEMS THAT THE PROTECTION IS TOO SHORT: THE NEEDLE IS UNPROTECTED.
Patient problems: Abrasion; Needle Stick/Puncture
MAUDE report 19739109 ↗
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- 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
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- 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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