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

Model Number	FX802T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a m.Blue (#fx802t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system (sprung reservoir + m.Blue) showed a drainage problem.The patient underwent a revision procedure.The complaint devices were returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.The release for investigation is missing, so the examination could not be started.Same event as medwatch#3004721439-2023-00170.
Additional Manufacturer Narrative
Manufacturing and quality control data: the m.Blue® was manufactured by a qualified employee on october 2021.Deviations during assembly did not occur.The product was finally tested as article fx802t and released for packaging and sterilization and was sterilized by miethke.The m.Blue® has a normal pressure range of 10 to 50 cmh2o.A fixed opening pressure of 10 cmh2o in the horizontal position (differential pressure unit) and an additional adjustable gravitational unit of 0 to 40 cmh2o in the vertical position.Both realized in one valve.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at the gravitational unit set pressures and 0, 10, 20, 30 and 40 cmh2o at the differential pressure unit of 10 cmh2o, and were found to meet specifications.All tested parameters were assessed according to specifications.Conclusion information: an investigation was not possible because no release/questionnaire was sent to us.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the m.Blue®, since this documentation indicates that the valve is in perfect condition.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.Further actions: from our point of view, no further regulatory actions are required.

• 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: 17072180
• Report Number: 3004721439-2023-00171
• Device Sequence Number: 17836588
• Product Code: JXG
• UDI-Device Identifier: 04041906504410
• UDI-Public: 4041906504410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: FX802T
• Device Catalogue Number: FX802T
• Device Lot Number: 20055596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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