MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX804T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an m.Blue plus valve (#fx804t) was to be implanted during a procedure performed on (b)(6) 2026.According to the complainant, the valve did not drain the fluid after being implanted and working for approximately 3 minutes.A different shunt was used and the procedure resumed as normal.No patient complications were reported as a result of the procedure.The complained device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no deformations or damages of the valves were determined.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The results show that the valves are operating within the specified tolerances in their respective relevant position.Adjustment test: the valves were tested and both valves are adjustable to all pressure settings.Braking force and brake function test: the brake operates as expected and the braking force is within the given tolerance.Internal inspection: after dismantling of the valves, no organic deposits were found in both valves.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the shunt.The m.Blue plus operates within all specification.How the abovementioned functional impairment occurred is not clear to us at the time of examination.

• Brand Name: M.BLUE PLUS VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 24662494
• Report Number: 3004721439-2026-00071
• Device Sequence Number: 9344531
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: (01)04041906504793(11)250822(17)300821(10)20084913
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20084913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 62 KG