MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. EDS 3; SHUNT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

Patient's lumbar drain has broken proximal to the stopcock.Distal tubing changed.Lumbar drain came apart at the stopcock.Resident reported this had happened multiple times with this type of drainage collection system.
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manufacturer response for lumbar drain, codman eds 3, csf external drainage system (per site reporter).
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the rep told the resident this is a known problem and that the glue from the stopcock separates.

• Brand Name: EDS 3
• Type of Device: SHUNT
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 4176230
• MDR Text Key: 20455185
• Report Number: 4176230
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR