MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX802T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a m.Blue (#fx802t) was not adjustable before use.The product returned in opened sterile packaging.No patient injury was reported as a result of the malfunction.The shunt was returned for examination to the manufacturer.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no damage or other abnormalities of the valve was determined.Adjustment test: the valve was tested and adjustable in all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerance.Results : based on thr investigation results, no functional deviations or other abnormalities were determined.The m.Blue operates within all specification.At the time of the investigation, we are unable to explain how the above-mentioned adjustment issues arose.Upon receiving the sample, we noticed that the expiration date for shelf life had already passed.No further regulatory actions are required from our point of view.

• Brand Name: M.BLUE 10 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: 24927196
• Report Number: 3004721439-2026-00098
• Device Sequence Number: 5179775
• Product Code: JXG
• UDI-Device Identifier: 04041906504410
• UDI-Public: (01)04041906504410(17)260226(10)20052017
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/20/2026

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 Expiration Date: 03/01/2021
• Device Model Number: FX802T
• Device Catalogue Number: FX802T
• Device Lot Number: 20052017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2026
• 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