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

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  malfunction  

Event 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)
• Type of Device: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL; rue girardet 29; le locle jura, CH-24 00; SZ CH-2400
• Manufacturer Contact: martin dockter ; 5955 pacific center blvd.; san diego, CA 92121 ; 8584551115
• MDR Report Key: 7481714
• MDR Text Key: 107756218
• Report Number: 2023988-2018-00020
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704040941
• UDI-Public: 10886704040941
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 82-1735
• Device Catalogue Number: 821735
• Device Lot Number: 166700
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1