MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG NRFIT

Catalog Number	0331166-51
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is reported in retrospect based on a re-evaluation conducted in 2025 for formal reasons.There was no particular risk to patients, users, or third parties.
Event or Problem Description
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.

• Brand Name: EPILONG NRFIT
• Common Device Name: EPILONG NRFIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 22436791
• Report Number: 9611612-2025-00034
• Device Sequence Number: 3153049
• Product Code: BSO
• UDI-Device Identifier: 04048223053218
• UDI-Public: 04048223053218
• Combination Product (Y/N): N
• PMA/510(K) Number: K060311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/19/2025
• Device Catalogue Number: 0331166-51
• Device Lot Number: 1370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown