MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 82-1707

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

While trying to insert codman lumbar drain catheter, a portion of the catheter sheared off in the patient.(portion described as a couple of millimeters by surgeon).Retained surgical item.Surgeon informed of his responsibility to tell family.Catheter sequestered and given to charge nurse.

• Brand Name: CODMAN LUMBER CATHETER KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8105391
• MDR Text Key: 128395703
• Report Number: 8105391
• 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: 11/26/2018,11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82-1707
• Device Catalogue Number: 82-1707
• Device Lot Number: HR1796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2018
• Date Report to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA