MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION VENTRICULOSTOMY SET; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Lot Number 3291037

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

Upon first encounter with patient left ventriculostomy was found to be broken at the point where the transducer attaches to buretrol.Cerebrospinal fluid was found to be dripping out at this particular point.Patient was alert and talking.No harm was immediately recognized.Ventric was clamped to patient and sterile gauze was wrapped around both open ports in the system to help prevent infection.Picu resident as well as neurosurgery resident were paged.A new ventriculostomy was set up per protocol and neurosurgery was at bedside to replace unit.Old broken unit was saved and tagged in order to be reviewed.

• Brand Name: VENTRICULOSTOMY SET
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 9792730
• MDR Text Key: 182191527
• Report Number: 9792730
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2019,12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3291037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Date Report to Manufacturer: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA