MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY 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	04/01/2019
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 there was a problem of leakage that occurred during the use of the cerebrospinal fluid drainage kit.It was stated the product was damaged and replaced with a new one.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the device leakage occurred in the ward.There were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned product was patent.There was tape, cotton, and string tied along the tubing and on the patient line stop cock.The catheter attached to the patient line had cotton, tape, and string wrapped around the catheter itself as well as the connection between the catheter and the patient line.The product did not meet the requirements for leak test due to cracks in the stopcock of the patient line.Two of the stopcocks that connects the patient line with the tubing connected to the chamber.The one not attached to the system had cracks on two of the outlets.It is unknown how this damage occurred.The instructions for use cautions, ¿all connections should be finger tightened.Over tightening can cause cracks and leaks to occur.Leakage could result in complications such as patient infection, underdrainage or overdrainage, as well as user infection.¿ proteinaceous debris was observed on the interior of the edms in the patient line.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXACTA 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: 8518981
• Report Number: 2021898-2019-00151
• Device Sequence Number: 1465815
• 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,Followup,Followup
• Report Date (Section B): 05/28/2019

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: 11/30/2021
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 212449809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 05/15/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/08/2019; 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR