MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDI-SHUNTASSTISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV288T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) the valve was returned in a plastic container with unknown liquid.Manufacturing and quality control data: the paedishuntassistant was manufactured by a qualified employee; deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a fixed pressure of 10 cmh2o.The valve was inspected as article fv288t.All parameters have been approved and assessed as meeting specifications during the manufacturing process.Summary: on the basi:s of juristic requirements, the surgeon must provide a personal request as a step of safeguard.Unforunately, no consent was received from the surgeon.An official release is missing for the investigation of the product.For this reason, the product was returned for discharge without examination.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from (b)(4) kg.No further actions required.
Event or Problem Description
According to the complainant a shunt assistant was not functioning as expected.According to the complainant, the shunt system was not working properly when put together and inline, but each component (reservoir, valve, & shunt assist) seemed to work individually.The surgeon took out the valve system and replaced it with all new components of the same product.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Further details were not provided.Weight: (b)(6).Associated medwatch: 3004721439-2021-00765.

• Brand Name: PAEDI-SHUNTASSTISTANT 10
• 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: 12919455
• Report Number: 3004721439-2021-00766
• Device Sequence Number: 12159871
• Product Code: JXG
• UDI-Device Identifier: 04041906113001
• UDI-Public: 4041906113001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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 Model Number: FV288T
• Device Catalogue Number: FV288T
• Device Lot Number: 20032153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2016
• 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: Other
• Patient Age: 2 MO
• Patient Sex: Unknown