MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46913
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the external ventricular drain (evd) tubing pulled out from the stopcock.It was noted the tubing is cemented into the stopcock and shouldn't pull out.It was unknown how long the device was in use before the failure occurred.It was stated that the patient who was a very young child was being held in the patient's mother's arms at the bedside when the tubing pulled out.It was asked if the mother was moving around or was there any evidence of the tubing getting hooked on something that put undo tension on it, and the nurse said they did not see a reason for this to happen.

• Brand Name: DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7452738
• Report Number: 2021898-2018-00215
• Device Sequence Number: 1233811
• Product Code: GWM
• UDI-Device Identifier: 00613994445360
• UDI-Public: 00613994445360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 46913
• Device Catalogue Number: 46913
• Device Lot Number: 213807266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR