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

Model Number	46914
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
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 clip on the main stopcock system was broken and would not hold the stopcock in place.The system was broken on 2 different external ventricular drainage (evd) systems right out of the box.Icu only stocked 2 systems at any given time.The nurses noticed the defect during priming prior to attaching to the patient.It was noted the nurses had to borrow from the or during the crisis situation.It was stated that this was a patient safety concern as the intracranial pressure measurement would be inaccurate and the cerebrospinal fluid may drain out of the patient's head at a rapid rate with a risk of mortality.

• Brand Name: DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10241793
• Report Number: 9612164-2020-02461
• Device Sequence Number: 2432617
• Product Code: GWM
• UDI-Device Identifier: 00613994445377
• UDI-Public: 00613994445377
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K983799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 10/22/2022
• Device Model Number: 46914
• Device Catalogue Number: 46914
• Device Lot Number: 218667160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1