MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV063T
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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 pediatric sprung reservoir (#fv063tt) was was using.The surgeon removed the reservoir from its packaging and tested it by introducing fluid and pumping it through the reservoir using thrid party catheters.The reservoir did not function as expected, as it failed to pump fluid in and out of the catheters.No incident cause, patient harm or delay in the surgery was reported.The sample will be returned for examination to the manufacturer.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no damage or other abnormalities were determined.Permeability test: a permeability test has shown that the reservoir is permeable.Result : in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried residues of testing liquid can influence the function of the product, which can affect the results.Despite this, we have examined the products.Based on our investigation results, we can determine no functional deviation.The reservoir operates within all specifications.The cause of the aforementioned functional impairment is not known to us at the time of the examination.We can exclude a defect at the time of release.The reservoir 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 pediatric sprung reservoir (#fv063tt) was was using.The surgeon removed the reservoir from its packaging and tested it by introducing fluid and pumping it through the reservoir using thrid party catheters.The reservoir did not function as expected, as it failed to pump fluid in and out of the catheters.No incident cause, patient harm or delay in the surgery was reported.The samplewas returned for examination to the manufacturer on 01/06/2026.

• Brand Name: PED.SPRUNG 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: 23759371
• Report Number: 3004721439-2025-00380
• Device Sequence Number: 21375007
• Product Code: JXG
• UDI-Device Identifier: 04041906142308
• UDI-Public: (01)04041906142308(17)290930(10)20078016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110206
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: FV063T
• Device Catalogue Number: FV063T
• Device Lot Number: 20078016
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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