• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 0 VALVE W/PERITONEAL CATHETER HYDROCEPHALUS MANAGEMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 0 VALVE W/PERITONEAL CATHETER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX805T
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative
Investigation results: visual inspection: the product showed clearly signs of mould and slightly scratches on the housing. Additional are visible deposits in the outlet spout. Permeability test: the test showed that the m. Blue 10 is permeable. Computer controlled test: the computer controlled test has shown the opening pressure of the m. Blue 10, at a reference flow rate of 20 ml/hr in a horizontal position, to be 8. 37 cmh2o. This is within the specified tolerance of 10 cmh2o ± 3 cmh2o. Additionally, the m. Blue 10 was tested according to standard procedure in the vertical position. At an opening pressure of 8 cmh2o in the vertical position, a pressure of 15 cmh2o ± 9 cmh2o is expected. The results indicated that at a reference flow of 20 ml/hr in the vertical position, the m. Blue 10 had a pressure of 10. 14 cmh2o. This is within the specified tolerance of 15 cmh2o ± 9 cmh2o. Adjustability test: the m. Blue 10 was found to be adjustable to all pressure settings. Braking force and brake function test: the braking force of the m. Blue 10 ® was within the specified tolerance and the brake function operated as expected. Internal inspection of product: after dismantling of the valve, some deposits were found in m. Blue 10. Results: based on our investigation, we are not able to substantiate the claim of "non- adjustability" or "blockage". However, we assume that the significant deposits found within the valve may have temporarily caused the functional impairment. Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy. We can exclude a defect at the time of release. The valve met all specifications of the final inspection when released from christoph miethke (b)(4). From our point of view, no further regulatory actions are required.
 
Event Description
It was reported that there was a problem with a m. Blue valve. "shunt working but non adjustable. " implantation: (b)(6) 2019. Removal: (b)(6) 2020. Patients information : height and gender are not available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM.BLUE 0 VALVE W/PERITONEAL CATHETER
Type of DeviceHYDROCEPHALUS 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 Key10430520
MDR Text Key203646742
Report Number3004721439-2020-00169
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K192266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX805T
Device Catalogue NumberFX805T
Device Lot Number20039979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/20/2020 Patient Sequence Number: 1
-
-