MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOPLEX® STIM

Catalog Number	001185-74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
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 lithuania.A supraclavicular block of the brachial plexus was performed under ultrasound guidance to anesthetize the patient.After successfully visualizing the plexus and extracting potentially defective regional anesthesia needle with the local anesthetic mixture, the latter dislodged from the plastic hub retainer and remained under the skin.The intervention site was examined by ultrasound revealing a solid needle still present in the subcutaneous tissue, but the tip of the needle couldn't be reached from the outside.The plastic surgeon on duty was urgently informed and arrived promptly.Under lidocaine-anesthetized ultrasound guidance, the shoulder area tissues were separated and the foreign body (needle) removed.After removal it was confirmed that the needle was solid, and ultrasound further confirmed that no parts of the needle remained in the tissues.

• Brand Name: SONOPLEX® STIM
• Common Device Name: SONOPLEX® STIM
• 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: 22436774
• Report Number: 9611612-2025-00029
• Device Sequence Number: 3152559
• Product Code: BSP
• UDI-Device Identifier: 04048223103463
• UDI-Public: 04048223103463
• Combination Product (Y/N): N
• PMA/510(K) Number: K243682
• 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: 001185-74
• Device Lot Number: 1472.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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