MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOTAP® II NRFIT®; SONOTAP® II NRFIT®_FASCIAL PLANE BLOCKS AND PERIPHERAL NERVE BLOCK NEEDLE

Model Number	1265-3E080
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Lors de la réalisation d'un bloc très profond, il a été constaté que l'aiguille s'est cassée en son embout lors d'un léger changement de direction afin d'affiner l'image.Le médecin a réussi à retenir l'aiguille afin d'éviter la perte in situ chez le patient de 21 ans.Il n'y a pas eu de conséquence clinique mais cet incident a présenté le risque de la perte in situ.Il s'agit du premier incident de ce type.During the performance of a very deep block, the needle was found to have broken off at its tip during a slight change of direction to refine the image.The doctor managed to retain the needle to avoid in situ loss in the 21-year-old patient.There were no clinical consequences, but this incident presented the risk of in situ loss.This is the first incident of its kind.
Additional Manufacturer Narrative
Event took place in france.The facts of the case, relevant tests are currently in process.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn #: (b)(6).Lors de la réalisation d'un bloc très profond, il a été constaté que l'aiguille s'est cassée en son embout lors d'un léger changement de direction afin d'affiner l'image.Le médecin a réussi à retenir l'aiguille afin d'éviter la perte in situ chez le patient de 21 ans.Il n'y a pas eu de conséquence clinique mais cet incident a présenté le risque de la perte in situ.Il s'agit du premier incident de ce type.[translation: during the performance of a very deep block, the needle was found to have broken off at its tip during a slight change of direction to refine the image.The doctor managed to retain the needle to avoid in situ loss in the 21-year-old patient.There were no clinical consequences, but this incident presented the risk of in situ loss.This is the first incident of its kind.].
Additional Manufacturer Narrative
Event took place in france.The facts of the case, relevant tests are currently in process.In case new information becomes available a follow up report will be sent to the agency.
Additional Manufacturer Narrative
Event took place in france.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoring 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# (b)(4).Lors de la réalisation d'un bloc très profond, il a été constaté que l'aiguille s'est cassée en son embout lors d'un léger changement de direction afin d'affiner l'image.Le médecin a réussi à retenir l'aiguille afin d'éviter la perte in situ chez le patient de 21 ans.Il n'y a pas eu de conséquence clinique mais cet incident a présenté le risque de la perte in situ.Il s'agit du premier incident de ce type.During the performance of a very deep block, the needle was found to have broken off at its tip during a slight change of direction to refine the image.The doctor managed to retain the needle to avoid in situ loss in the 21-year-old patient.There were no clinical consequences, but this incident presented the risk of in situ loss.This is the first incident of its kind.

• Brand Name: SONOTAP® II NRFIT®
• Common Device Name: SONOTAP® II NRFIT®_FASCIAL PLANE BLOCKS AND PERIPHERAL NERVE BLOCK NEEDLE
• 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: 19711739
• Report Number: 9611612-2024-00010
• Device Sequence Number: 12991904
• Product Code: CAZ
• UDI-Device Identifier: 04048223116241
• UDI-Public: 04048223116241
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113207
• 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): 07/17/2024

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
• Device Model Number: 1265-3E080
• Device Catalogue Number: 1265-3E080
• Device Lot Number: 1518
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 07/04/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/11/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown