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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EDS3 EXTERNAL DRAINAGE SYSTEM

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CODMAN & SHURTLEFF, INC. CODMAN EDS3 EXTERNAL DRAINAGE SYSTEM Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
As reported by a user facility "bloody csf not draining from burette to bag. Gets trapped in narrow tubing: "the tubing connecting the burette to the drainage bag is smaller in diameter than the accudrain tubing connecting burette to bag. Given that they use this drain primarily for subarachnoid hemorrhages, the drainage is more viscous as there is blood in the csf. Bloody csf not draining from brurette to bag. Gets trapped in narrow tubing. No issues with other drainage systems that they used in the past. Collection bag difficult to unscrew from tubing connecting burrette to the bag. Resulted in breaking system. As it is hand tightened, expectation is to easily disconnect from tubing without need for force or having to use additional tools. " additional information received via email from dr. (b)(6) at the facility on 30april2018: "some of our low pressure patients have required evd drainage as low as -10 cm below the external auditory canal for prolonged periods. This subzero technique (negative pressure drainage method) was first reported in the pang et al. Reference included in the attached article for low pressure hydrocephalus patients. The current evd setup does not accommodate these patients. " several attempts have been made to obtain more information: request for additional information: 01may2018. Request for additional information:09may2018. Request for additional information: 10may2018. Request for additional information: 24may2018.
 
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Brand NameCODMAN EDS3 EXTERNAL DRAINAGE SYSTEM
Type of DeviceEXTERNAL DRAINAGE SYSTEM
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
5955 pacific center blvd
san diego CA 92121
Manufacturer Contact
martin dockter
5955 pacific center blvd.
san diego, CA 92121
8584551115
MDR Report Key7541881
MDR Text Key109505699
Report Number2023988-2018-00023
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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