MAUDE Adverse Event Report: CODMAN EXTERNAL DRAINAGE SYSTEM III; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 821730

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Rep reported that "at distal end of system, the tubing "came apart" at both points to either side of the stop-cock.(b)(6) 2012, it is the reps understanding that the breakage occurred when the nurse was fidgeting with it.I have been asked to contact tim kline for additional clarification.(b)(6): additional information from (b)(6) explained that the nurse was not aware that the device had fallen apart until the patient was observed.When she notice the line had disconnected she reattached.When the doctor was notified the nurse was instructed to discontinue use and the system was replaced.(b)(6) 2014: we recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.Please refer to complaint (b)(4) 2012.A follow up is being filed as a result is missing in the medwatch report.

Manufacturer Narrative

(b)(4)1 204: we recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.

• Brand Name: CODMAN EXTERNAL DRAINAGE SYSTEM III
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3751895
• MDR Text Key: 4555012
• Report Number: 1226348-2014-11380
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 821730
• Device Lot Number: CLNB1M
• Date Manufacturer Received: 04/15/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention