MAUDE Adverse Event Report: MEDTRONIC MEXICO BECKER,BC NDLESS,BOND CONN; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 27779

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

Medtronic received information regarding an external drainage and monitoring system.It was reported that the system with cerebrospinal fluid (csf) in the tubing drained into the collection bag below the 2 clamps which were closed in the morning as well as csf leaking from the tubing below the graduated cylinder.The tubing fully drained and discussed with the nurse about closely watching if it reoccurred.In the evening, the same issue occurred and questioned if a product issue was with the clamps as they were not fully occluding the drainage.A blue plastic clamp was applied to prevent any unaccounted csf that may be draining into the bag inadvertently and not being accounted for in the hourly drainage of this device.However, the device was replaced with another one of the same unit.The patient's status at the time of the report was alive-no injury.

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.

• Brand Name: BECKER,BC NDLESS,BOND CONN
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19031835
• MDR Text Key: 339235717
• Report Number: 9612164-2024-01573
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 00763000333591
• UDI-Public: 00763000333591
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K984053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Model Number: 27779
• Device Catalogue Number: 27779
• Device Lot Number: 227467158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/03/2024
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1