MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO II NANOLINE®; STIMULONG SONO II NANOLINE®_ANESTHESIA CONDUCTION KIT

Model Number	BA110051
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn# 062-25_968 incident occurred in brazil: the incident was at first reported to anvisa (br) on 01/13/2025 under the reporting case number (b)(4).The incident did not take place in the usa but is co-reported.Based on risk assessment and clinical assessment this file 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 # 062-25_968 incident occurred in brazil: during the material testing, it was found that the device was obstructed.

• Brand Name: STIMULONG SONO II NANOLINE®
• Common Device Name: STIMULONG SONO II NANOLINE®_ANESTHESIA CONDUCTION KIT
• 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: 21717188
• Report Number: 9611612-2025-00006
• Device Sequence Number: 17307435
• Product Code: CAZ
• UDI-Device Identifier: 04048223117095
• UDI-Public: 04048223117095
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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 Expiration Date: 12/21/2025
• Device Model Number: BA110051
• Device Catalogue Number: 521187-32C
• Device Lot Number: 1379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown