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

Model Number	FX824T
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the missing product, the investigation is restricted to traceability of manufacturing and quality control data.Miethke can assure you that all products are manufactured by qualified staff and individually tested before they are placed on the market.Based on the product documentation, a defect at the time of delivery of the ventricular catheter can be excluded.The traceability indicates that the catheter was in perfect condition at the time of shipment.A meaningful analysis/ final conclusion is only possible with a sample.The photo from the customer and similar complaints where samples were available indicated damage caused by sharp instruments during the preparation.No other complaints regarding this batch are reported.No further actions are required as a result of the complaint.
Event or Problem Description
It was reported that during the preparation the ventricular catheter (part of #fx824t) was broken off.The complained product is not available for investigation.Another shunt was opened and no delay or other complications were reported as a result of the malfunction.

• Brand Name: M.BLUE PLUS SYS WITH CONTROL 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: 24865581
• Report Number: 3004721439-2026-00094
• Device Sequence Number: 9036990
• Product Code: JXG
• UDI-Device Identifier: 04041906504830
• UDI-Public: (01)04041906504830(11)251119(17)301113(10)20086660
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 05/18/2026

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 Model Number: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20086660
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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