MAUDE Adverse Event Report: MEDTRONIC DUET EXTERNAL DRAINAGE SYSTEM; EVD DRAINAGE SYSTEM

Lot Number CE

Device Problems Disconnection (1171); Sticking (1597)

Patient Problem No Information (3190)

Event Date 06/29/2015

Event Type  Injury  

Event Description

The pt was hospitalized for subarachnoid hemorrhage and intraventricular hemorrhage.She required a ventriculostomy.The external ventricular drainage bag got stuck in the device and the nurse was unable to loosen the bag from the device.The hub of the drainage bag became disconnected from the bag itself causing the bag to become completely disconnected from the device.The hub which was stuck into the device was removed by a physician and the hub and the bag were collected for examination by the mfr.

• Brand Name: DUET EXTERNAL DRAINAGE SYSTEM
• Type of Device: EVD DRAINAGE SYSTEM
• Manufacturer (Section D): MEDTRONIC; houston TX 77070
• MDR Report Key: 4922025
• MDR Text Key: 6015180
• Report Number: MW5044268
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 54