MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM WITH PRECHAMBER 9/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV306T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the valve (#fv306t) was not draining before use, so another valve was used to perform the operation.The valve was sent dry in ne sealed sterile packaging to the manufacturer for examination.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, visible deposits in the inlet spout and on the valve were determined.Permeability test: a permeability test has shown that the valve has a blockage.After removing the inlet valve grommet, both components were permeable.Internal inspection : after dismantling of the valve, no visible deposits were found in paedigav.Results: in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we can determine a blockage on the valve during the first permeability test.After dismantling the inlet valve spout, both components were permeable.The visible dry deposits in the inlet spout may have led to the blockage.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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.

• Brand Name: PAEDIGAV SYSTEM WITH PRECHAMBER 9/24
• 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: 19126915
• Report Number: 3004721439-2024-00088
• Device Sequence Number: 7621462
• Product Code: JXG
• UDI-Device Identifier: 04041906131210
• UDI-Public: 4041906131210
• Combination Product (Y/N): N
• Initial Reporter Country: RW
• PMA/510(K) Number: K011030
• 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): 04/17/2024

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
• Device Expiration Date: 01/09/2026
• Device Model Number: FV306T
• Device Catalogue Number: FV306T
• Device Lot Number: 20045611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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