MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE UNIPLEX® NANOLINE®

Catalog Number	001156-74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Incident occurred in brazil: the material used broke during the procedure.
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.

• Brand Name: UNIPLEX® NANOLINE®
• Common Device Name: UNIPLEX® NANOLINE®
• 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: 22436772
• Report Number: 9611612-2025-00028
• Device Sequence Number: 3152558
• Product Code: BSP
• UDI-Device Identifier: 04048223043486
• UDI-Public: 04048223043486
• Combination Product (Y/N): N
• PMA/510(K) Number: K053283
• 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 Catalogue Number: 001156-74
• Device Lot Number: 1471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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: Required Intervention
• Patient Sex: Unknown