EpiLong II 033115201-51Recalls & reported problems
Pajunk GmbH Medizintechnologie · EpiLong II Tuohy II needle 18G x 90mm, with plastic stylet · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 04048223119495), received between Dec 10, 2024 and Sep 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Product Quality Problem1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Fracture; Fracture
IRN# (B)(4) INCIDENT OCCURRED IN (B)(6): UPON COMPLETION OF THE PROCEDURE, DURING CATHETER WITHDRAWAL, THE DISTAL TIP OF THE CATHETER WAS RETAINED WITHIN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23051994 ↗MalfunctionDec 10, 2024Product Quality Problem; Product Quality Problem
IRN# (B)(4) INCIDENT OCCURRED IN ITALY: TEXT FROM THE FIRST COMPLAINT WITH INSUFFICIENT DESCRIPTION: ACCIDENTAL DURAL PUNCTURE WITH A DEVICE THAT HAS SHOWN, AFTER USE, A WELDING DEFECT, THIS DEFECT HAS BEEN OBSERVED IN OTHER DEVICES WITH THE SAME LOT. OF THE PATIENT WE KNOW HAS HAD A WORSENING OF HEALTH STATUS AND PROLONGED ILLNESS AFTER HOSPITAL DISCHARGE. PAJUNK WAS ASKED TO DESCRIBE THE INCIDENT AND THE PRODUCT DEFECT IN MORE DETAIL / RESULT: ON (B)(6) 2024, PAJUNK GMBH RECEIVES THE INFORMATION VIA MOVI THAT, THE SUBJECT OF THE OFFICIAL REPORT WAS LESS SERIOUS THAN EXPECTED AND THE ACTUAL NEEDLE DEFECT WAS ALSO BADLY DESCRIBED. PROBLEM IS THAT THERE IS A LEAKAGE IN THE PLASTIC HUB OF THE TUOHY II". NOTE: REJECTED SAMPLE WILL BE DELIVERED ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 20892442 ↗
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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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