MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27703
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	09/14/2020
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 the patient was admitted to the hospital with convulsions on (b)(6) 2020.The patient was diagnosed with hydro cephalus, brain contusion, and laceration.On (b)(6), they were sent to the operating room for intracranial hematoma removal, decompressive craniectomy, ventricular drainage, and indwelling ventricle drainage tube.When the nurse visited the ward on (b)(6), it was found that the fluid in the ventricular drainage bag was full.When the drainage fluid was poured, the drainage bag was found to be disconnected from the junction of the metering tube and the drainage bag.The patient was drowsy; however, their vital signs were stable.Immediately, a sterile sheet was spread for the patient, the connection of drainage bag and the tube end were sterilized, and this situation was reported to the doctor.The doctor reinforced and connected the metering tube and the drainage bag in aseptic operation.The junction between the metering tube and the drainage bag was reinforced with sutures.

• Brand Name: EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10922824
• Report Number: 2021898-2020-00356
• Device Sequence Number: 2127551
• Product Code: GWM
• UDI-Device Identifier: 00643169496880
• UDI-Public: 00643169496880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/30/2020

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: 10/31/2024
• Device Model Number: 27703
• Device Catalogue Number: 27703
• Device Lot Number: E74433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR