MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG VENTRICULAR CATHETER MARKED 250MM; HYDROCEPHALUS MANAGEMENT

Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: conclusion information: due to the missing product information (e.G.Delivery note, batch), we were unable to trace the production and sterilization data of the affected product.Miethke assures that all products are manufactured and sterilized by qualified staff and individually tested before distribution.Products are only packaged and shipped once the sterilization process has been successfully completed.A more meaningful explanation might be possible based on the product data or the sample.However, the causes of an infection can be very complex and a clear explanation is not possible.We can exclude a problem at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.Actions: no further actions are required as a result of the complaint.
Event or Problem Description
Customer reported a case of infection with a vetricular cathter (#fv077p) no patient data available.No patient harm reported.Same event as #3004721439-2025-00259, #3004721439-2025-00260.

• Brand Name: VENTRICULAR CATHETER MARKED 250MM
• 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: 23017658
• Report Number: 3004721439-2025-00258
• Device Sequence Number: 9512184
• Product Code: JXG
• UDI-Device Identifier: 04041906120405
• UDI-Public: 4041906120405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200950
• 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): 09/10/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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