MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX800T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

It was reported that a m.Blue (#fx800t) which was intended to be implanted, could not be adjusted in the sterile packaging.The surgeoun was able to use another fx800t from the stock.The complainant device will returned to the manufacturer for evaluation.No patient impairment was reported.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation result: the opening pressure on delivery was 36 cmh2o (not original pressure setting as on delivery 20 cmh2o).On visual inspection, the valve showed crystalline external deposits, but no damage.The valve could be adjusted in all pressure stages and the brake function and braking force were fully functional and within specification.Based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementionedfunctional impairment occurred is not clear to us at the time of examination.

• Brand Name: M.BLUE VALVE
• Type of Device: 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: 18551709
• MDR Text Key: 333379530
• Report Number: 3004721439-2024-00007
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: 4041906504397
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Device Model Number: FX800T
• Device Catalogue Number: FX800T
• Device Lot Number: 20065238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention