MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER

Model Number	82-1730
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by an international user facility: "after 4 days an eds3 started leaking.It was replaced by another external drain.There were no reports of delay or patient harm".Patient information: n/a.Patient is not part of a clinical study.No surgical delay reported.This is not a revision of one or more implants.On (b)(6) 2018: the device will not be returned.

• Brand Name: CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
• Common Device Name: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7809479
• Report Number: 2023988-2018-00048
• Device Sequence Number: 13830561
• Product Code: JXG
• UDI-Device Identifier: 10886704040903
• UDI-Public: 10886704040903
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K162437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-1730
• Device Catalogue Number: 821730
• Device Lot Number: 151701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention