MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV DRAINAGE BAG; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46912
Medical Device Problem Codes	Disconnection (1171); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported the healthcare professional (hcp) went to change the device's bag as it was 3/4 full.When the hcp went to remove the bag from leur lock system, they were unable to remove the old bag.The hcp required kelly clamps to remove the old bag from the system.When the hcp was using the kelly clamps to remove the old bag, the bag disconnected from the leur lock system and fell to ground and did leak minimally from the top of bag.However, the leur lock of old bag remained in place even through the bag disconnection.The hcp was able to successfully remove the bag after great difficulty with the kelly clamps.The system end was cleaned with chlorohexidine and the bag spout.Both were allowed to dry before connecting the new drainage bag.

• Brand Name: DRAINAGE BAG
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 22519002
• Report Number: 9617601-2025-00636
• Device Sequence Number: 8560303
• Product Code: GWM
• UDI-Device Identifier: 00763000431273
• UDI-Public: (01)00763000431273(17)261109(10)227381175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K802100
• 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): 07/16/2025

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 Model Number: 46912
• Device Catalogue Number: 46912
• Device Lot Number: 227381175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown