MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO NANOLINE; SONOLONG ECHO NANOLINE_ANESTHESIA CONDUCTION KIT

Catalog Number	531185-31A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This incident took place in germany.Additional information: it was not possible to determine exactly which batch was affected, as the packaging had been disposed of by the clinic.Two possible batches are therefore being investigated.Lot: 1588, mfr 2025-05-28, and exp 2030-05-27, lot: 1589, mfr 2025-06-04, and exp 2030-06-03.This case is considered as closed.If further information becomes available an update will be sent to the agency.
Event or Problem Description
(b)(4).This incident took place in germany.Tentitive translation: the catheter has remained inside the patient; the sheared-off section is approximately 3-5 cm long.An ultrasound scan is currently being carried out to locate it, and a medical decision will be made regarding the best course of action for the patient.

• Brand Name: SONOLONG ECHO NANOLINE
• Common Device Name: SONOLONG ECHO NANOLINE_ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen 78187-- ; GM 78187-
• MDR Report Key: 25092267
• Report Number: 9611612-2026-00009
• Device Sequence Number: 4864707
• Product Code: CAZ
• UDI-Device Identifier: 04048223126806
• UDI-Public: 04048223126806
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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 Catalogue Number: 531185-31A
• Device Lot Number: 1588 (OR 1589)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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; Other
• Patient Sex: Unknown