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

Model Number 82-1706

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

While inserting the lumbar drain the anesthesiologist met resistance so he pulled the catheter out.The catheter was noted to be sheared and may have left a plastic piece in the patient.

• Brand Name: CODMAN
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7233509
• MDR Text Key: 98753946
• Report Number: 7233509
• 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: 01/26/2018,01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 82-1706
• Device Catalogue Number: 821706
• Device Lot Number: 104383
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 64 YR