MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE® NRFIT®; PLEXOLONG NANOLINE® NRFIT®_ANAESTHESIA CONDUCTION KIT

Model Number	521166-31A
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in france.The product analysis has been in progress since the initial notice dated 09/18/2024.And will be published with the test results in the follow-up report.
Event or Problem Description
Irn# (b)(4).Catheter adapter appears to crush the catheter, making injection impossible.
Event or Problem Description
Irn# (b)(4).Event took place in france.Catheter adapter appears to crush the catheter, making injection impossible.
Additional Manufacturer Narrative
Event took place in france.Based on clinical assessment and risk assessment this report is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Event took place in france.Catheter adapter appears to crush the catheter, making injection impossible.
Additional Manufacturer Narrative
Event took place in france.Correction 08/11/2024: manufacturing date change to 06/20/2023.Based on clinical assessment and risk assessment this report is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: PLEXOLONG NANOLINE® NRFIT®
• Common Device Name: PLEXOLONG NANOLINE® NRFIT®_ANAESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 20244288
• Report Number: 9611612-2024-00022
• Device Sequence Number: 17962443
• Product Code: CAZ
• UDI-Device Identifier: 04048223067451
• UDI-Public: 04048223067451
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 521166-31A
• Device Catalogue Number: 521166-31A
• Device Lot Number: 1496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 09/18/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/09/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown