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

Model Number	27779
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
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.
Additional Manufacturer Narrative
H3.Product analysis determined that the returned edms system had several biological debris and a drainage bag full of blood.Considering the nature of pressurized testing and safety of lab personnel, decontamination/testing was not permitted on the returned device.The device was discarded due presence of a big pool of blood in the product.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
• Common Device Name: 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
• Report Number: 9612164-2024-01573
• Device Sequence Number: 8187398
• Product Code: GWM
• UDI-Device Identifier: 00763000333591
• UDI-Public: 00763000333591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: 27779
• Device Catalogue Number: 27779
• Device Lot Number: 227467158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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