MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W/PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX816T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue 5 sys w/ped.Control reservoir (part # (b)(4)) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: unknown, weight: (b)(6), gender: female.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has indicated that the valve has a blockage.Adjustment test: the m.Blue valve was tested and is not adjustable throughout the normal range.Klickforce and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Computer controlled test: not applicable.Internal inspection : after dismantling of the valve, deposits were found in the valve results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.Based on our investigation results, we can determine clogging and non-adjustability of the valve at the time of our investigation.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.No further regulatory actions are required from our point of view.

• Brand Name: M.BLUE 5 SYS W/PED.CONTROL 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: 13196283
• Report Number: 3004721439-2021-00357
• Device Sequence Number: 14517416
• Product Code: JXG
• UDI-Device Identifier: 04041906504441
• UDI-Public: 4041906504441
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 02/24/2025
• Device Model Number: FX816T
• Device Catalogue Number: FX816T
• Device Lot Number: 20046433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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 Age: 4.5 MO
• Patient Sex: Female
• Patient Weight: 5 KG