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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
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.
 
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Brand NameCODMAN LUMBER CATHETER KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key8105391
MDR Text Key128395703
Report Number8105391
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number82-1707
Device Catalogue Number82-1707
Device Lot NumberHR1796
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/26/2018
Event Location No Information
Date Report to Manufacturer11/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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