MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN BACTISEAL EVD CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 82-1745

Device Problems Material Discolored (1170); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

This event occurred before the procedure so there was no patient or caregiver harm.The catheter set was being opened and it was discovered that there was no catheter included in the set only the trocar and stylette.Upon further inspection the distal tip of the stylette had a brownish/red stain.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount dr; raynham MA 02767 035
• MDR Report Key: 4459135
• MDR Text Key: 5183142
• Report Number: 4459135
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 82-1745
• Device Lot Number: CRKCVF
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1