MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EDS 3 CLEAR VENTRICULAR CSF CATHETER (1.5 X 3.1MM); EXTERNAL DRAINAGE SYSTEM

Model Number	82-1735
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on an excel spreadsheet received from codman "an eds3 was not sterile because of absense of weld at one end.There were no reports of delay or patient harm".Additional information has been requested.

• Brand Name: CODMAN EDS 3 CLEAR VENTRICULAR CSF CATHETER (1.5 X 3.1MM)
• Common Device Name: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7481714
• Report Number: 2023988-2018-00020
• Device Sequence Number: 238345
• Product Code: JXG
• UDI-Device Identifier: 10886704040941
• UDI-Public: 10886704040941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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
• Operator of Device: Other Health Care Professional
• Device Model Number: 82-1735
• Device Catalogue Number: 821735
• Device Lot Number: 166700
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/02/2018
• Patient Sequence Number: 1