MAUDE Adverse Event Report: LIFESCIENCES CORPORATION LUMBAR CATHETER ACCESSORY KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	910121
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During attempted lumbar drain placement, catheter unable to continue advancing.Upon catheter removal, part of the catheter was retained.Fda safety report id # (b)(4).

• Brand Name: LUMBAR CATHETER ACCESSORY KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): LIFESCIENCES CORPORATION
• MDR Report Key: 12590154
• Report Number: MW5104457
• Device Sequence Number: 3586092
• Product Code: JXG
• UDI-Device Identifier: 10381780034124
• UDI-Public: (01)10381780034124
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: No Information
• Device Expiration Date: 04/30/2024
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Device Lot Number: 0223596
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention