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

Model Number	46700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2020
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 valve below the drainage bag could not be screwed tight, and it would always drip and leak cerebrospinal fluid.The patient's status at the time of the report was alive-no injury.Additional information received reported that no chemicals of any type were used for cleaning the connections.It was also stated that there was no environmental/external/patient factors that may have led or contributed to the issue.

• Brand Name: EXACTA 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: 10066622
• Report Number: 9612164-2020-01901
• Device Sequence Number: 13647276
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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: 06/26/2024
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 218143942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO