MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W/PED.BURRHOLE RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX846T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that an m.Blue shunt system (#fx846t) showed adjustment difficulties preoperatively.No patient involment.The complained product was not yet sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Manufacturing site evaluation: visual inspection: the product was returned unopened sterilization packaging and in the original outer packaging.During the investigation, no significant deformations or damage of the valves was determined.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Results: based on our investigation results, we cannot determine any problems with the adjustment or other deviations of the valve.The fact that the valve is set to 30 cmh2o proves that the valve must have been adjustable.The opening pressure on delivery was set to 20 cmh2o.The examination of the return has been completed with the drafting of this report.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.
Event or Problem Description
It was reported that an m.Blue shunt system (#fx846t) showed adjustment difficulties preoperatively.No patient involment.The complained product was sent to the manufacturer for investigation.

• Brand Name: M.BLUE 5 SYS W/PED.BURRHOLE 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: 21949355
• Report Number: 3004721439-2025-00132
• Device Sequence Number: 8553955
• Product Code: JXG
• UDI-Device Identifier: 04041906504762
• UDI-Public: 4041906504762
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: FX846T
• Device Catalogue Number: FX846T
• Device Lot Number: 20080576
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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 Sex: Unknown