EPILONG 0331252-51Recalls & reported problems
Pajunk GmbH Medizintechnologie · 0331252-51 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223053218), received between Sep 17, 2024 and Jul 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
- 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.
InjuryJul 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IRN#: (B)(4). INCIDENT OCCURRED IN THE UK. ON (B)(6) 2023, I SITED A LUMBAR EPIDURAL UNEVENTFULLY IN A PATIENT UNDERGOING SURGERY. WHEN THE CATHETER WAS REMOVED TWO DAYS LATER, THE TERMINAL SECTION SHEERED OFF LEAVING 3MM IN THE EPIDURAL SPACE. THIS WAS CONFIRMED ON CT SCAN. THE VIEW OF ONE OF OUR SPINAL SURGEONS WAS THAT SURGERY TO ATTEMPT TO REMOVE THIS TERMINAL SECTION OF CATHETER WAS NOT INDICATED.
Patient problems: Foreign Body In Patient
MAUDE report 22436791 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IRN# (B)(6). DURING AN EPIDURAL INSERTION FOR LABOUR ANALGESIA THE HUB OF THE NEEDLE SHEARED OFF WITH NO UNDUE FORCE HAVING BEEN APPLIED RESULTING IN THE METAL NEEDLE BEING LEFT IN THE PATIENT'S BACK. FORTUNATELY I WAS ABLE TO GET HOLD OF THE END OF IT, JUST, AND REMOVE IT FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20234323 ↗
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- 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 Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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