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

Catalog Number INS-5010

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Patient's lumbar drain snapped when patient got back into bed from bathroom.Connecter pulled out of catheter.Drain clamped and hemostat placed on tubing.

• Brand Name: LUMBAR CATHETER ACCESSORY KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 5480638
• MDR Text Key: 39687705
• Report Number: 5480638
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: INS-5010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 86