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

Model Number 82-3073

Device Problems Material Discolored (1170); Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

Slit at the end of ventricular catheter as well as some discoloration.When attempting to place ventricular catheter in the patient the surgeon noticed the discoloration and a slit at the end of the catheter.The stylet was able to slide out of the catheter potentially causing injury.This was all noticed before use on the patient.

• Brand Name: CODMAN BACTISEAL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10514111
• MDR Text Key: 206334429
• Report Number: 10514111
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 82-3073
• Device Catalogue Number: 823073
• Device Lot Number: 4178253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1