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

Model Number	FX804T
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation.Investigation on-going.Should relevant additional information or the investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that an m.Blue plus (#fx804t) was implanted during a procedure performed on an unspecified date.According to the complainant, the shunt system caused an underdrainage and had adjustment difficulties.The patient underwent a revision procedure on an unspecified date.No patient complications were reported as a result of the revision procedure.The complained device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Manufacturing site evaluation.No product was sent in, we are closing the case.
Event or Problem Description
The complained device wasn't returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the m.Blue, but no significant deformations 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 operate within the specified tolerances in their respective relevant position.Adjustment test: the valves were tested and both valves are not adjustable in all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valves.Internal inspection: after dismantling of the valves, organic deposits were found in both valves.Results: based on our investigation results, we can determine adjustment difficulties in both valves.The determined organic deposits can be named as the cause for the functional deviations.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known inherent side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
Case initially closed without sample.Reopened complaint after receiving the product on october 1, 2025.The investigation of the product has been completed.

• 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: 22827121
• Report Number: 3004721439-2025-00233
• Device Sequence Number: 4564748
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20058607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/01/2024; 09/01/2024
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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