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

Model Number	82-1730
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on a spreadsheet received by natus on (b)(6) 2018, an eds3 (external drainage system) leaked at the proximal stopcock.Replaced with another; hospitalization of patient was extended.Additional information requested.
Additional Manufacturer Narrative
Additional information: patient information: no information received.No delay in surgery reported.This was not a revision of one or more implants.Three attempts were made for product followup.Natus has completed their investigation.The results forwarded by codman on (b)(6) 2018 (b)(4) included the referenced: methods: review of device history records.Review of complaints history.A review of complaint records for the previous 12 months could not be performed as no lot number information was provided.The most recent complaint and smt presentation was reviewed and did not show that this product family exceeded its upper control limit for complaints.Trends will be monitored for this or similar complaints.Investigation methods/evaluation results: complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Root cause category: undetermined : insufficient information.Failure code codman : product analysis : device not returned root cause description: complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.No further corrective & preventative actions proposed.Document rationale for no corrective action: no corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.This complaint is now deemed closed.Should the product be returned, the complaint may be reopened.

• Brand Name: CODMAN ESD 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: 7383045
• Report Number: 2023988-2018-00010
• Device Sequence Number: 16448042
• Product Code: JXG
• UDI-Device Identifier: 10886704040903
• UDI-Public: 10886704040903
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention