MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE W/DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV706T
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the form of quality assurance control, it can be ensured that this type of defect/damage to the sealing of this product can be excluded before dispatching.To avoid this type of defects, all packaging are visually checked several times by employees before the final quality assurance check.Every individual product is only packaged and shipped after the final quality assurance check.The outer box ensures additionally that the sterile packaging cannot be damaged during shipment.It is not clear, how the above-mentioned damage occurred.
Event or Problem Description
It was reported that the sterilization packaging had a poor sealing when unpacking and refused to use the device.The device/packaging was not returned to the manufacturer.Pictures with the problem was submitted.

• Brand Name: PROSA VALVE W/DIST.CATHETER
• 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: 20030805
• Report Number: 3004721439-2024-00230
• Device Sequence Number: 8674623
• Product Code: JXG
• UDI-Device Identifier: 04041906133559
• UDI-Public: 4041906133559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• 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): 08/21/2024

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: FV706T
• Device Catalogue Number: FV706T
• Device Lot Number: 20073095
• 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: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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
• Patient Sex: Unknown