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	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by codman to natus on 31may2018: "as reported by the ous affiliate, an eds iii was leaking at the 3 way stop cock.Another was used to complete the procedure.There were no reports of delay or patient harm." this is not a revision of one or more implants.Patient is not part of a clinical trial.Patient information: no information.
Additional Manufacturer Narrative
Additional information 31july2018: 18june2018: 2nd attempt for complaint sample.01july2018: per rep, no sample is being returned as the sample is still implanted.Action closed, investigator notified.Natus completed their investigation on 31july2018.Investigation results are as follows: investigation summary: as reported by the ous affiliate, an eds iii was leaking at the 3 way stop cock.Another was used to complete the procedure.There were no reports of delay or patient harm.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.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.A review of complaint records for the previous 12 months did not identify any confirmed similar complaints for this lot and product code combination.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.Is further corrective & preventative actions proposed? no 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.

• 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: 7626321
• Report Number: 2023988-2018-00036
• Device Sequence Number: 10814244
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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 Expiration Date: 11/30/2020
• Device Model Number: 82-1730
• Device Catalogue Number: 821730
• Device Lot Number: 167303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 07/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention