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

Model Number	FX846T
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
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 system (fx846) was not adjustable.Only limited information was provided in the customer complaint on the registration form.The response to the request for further information is still pending.No patient injuries or other complications were reported.The complained product will be returned to the manufacturer for investigation.
Additional Manufacturer Narrative
Manufacturing site evaluation: visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: not necessary.Computer controlled test: not necessary.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: not applicable, due to the packaging.Internal inspection: not necessary.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.In accordance to the documentation, the quality assurance department can rule out a defect before delivery.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 a m.Blue system (fx846t) was non-adjustable preoperatively.The complained product was sent to the manufacturer for investigation.

• Brand Name: M.BLUE 5 SYSTEM WITH 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: 21137063
• Report Number: 3004721439-2024-00426
• Device Sequence Number: 12628725
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 20076090
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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