MAUDE Adverse Event Report: VENTRICULAR CATHETER PROXIMAL

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2020

Event Type  Injury  

Event Description

(b)(6) pa was removing ventriculostomy drain and tubing severed inside patient.Dr.(b)(6) attempted to remove the rest in icu room but unable and required operating room visit to remove.

• Brand Name: VENTRICULAR CATHETER PROXIMAL
• Type of Device: VENTRICULAR CATHETER PROXIMAL
• MDR Report Key: 11850337
• MDR Text Key: 252018906
• Report Number: 11850337
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Distributor Facility Aware Date: 04/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR