MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE®

Catalog Number	521156-31A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
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 france: an anaesthetist placed an injection catheter preoperatively for analgesia after knee prosthesis.The catheter was inserted without any particular problem, but during injection, it bent and broke inside the patient.The surgeon in charge of the knee replacement had to make an incision in the patient's thigh in order to recover the broken end.

• Brand Name: PLEXOLONG NANOLINE®
• Common Device Name: PLEXOLONG 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: 22412898
• Report Number: 9611612-2025-00025
• Device Sequence Number: 12835650
• Product Code: BSP
• UDI-Device Identifier: 04048223116869
• UDI-Public: 04048223116869
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/07/2025

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: 521156-31A
• Device Lot Number: 1497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (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