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

Model Number	FX844T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an m.Blue plus shunt system (#fx844t) showed adjustment difficulties before the surgery.The complained product was not sent to the manufacturer for investigation.No patient complications were reported as a result of the procedure.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves were determined.It was still packaged in the original sterile packaging.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the packaging of the valve.Results: based on our investigation results, we cannot detect any functional deviations or other abnormalities in the product.It was possible to adjust the m.Blue to all pressure levels, the valve works within the specification.During the visual inspection of the product, we were able to read a delivery pressure level of 26cmh2o, and we noticed that a pressure level of 0cmh2o was visible on the adjustment tool on the outlet side.It is likely that the opening pressure was read incorrectly on the outlet side.As stated in the ifu (see: "m.Blue plus adjusting tool"), the desired pressure level must be read in the direction of the proximal catheter (leading to the valve).We can exclude a defect at the time of release.The valve 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.

• Brand Name: M.BLUE PLUS SYS M.SPRUNG RESERVOIR
• 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: 21873623
• Report Number: 3004721439-2025-00115
• Device Sequence Number: 12947059
• Product Code: JXG
• UDI-Device Identifier: 04041906504878
• UDI-Public: 4041906504878
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: FX844T
• Device Catalogue Number: FX844T
• Device Lot Number: 20079483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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