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	05/28/2018
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.Another was used to complete the procedure.There were no reports of delay or patient harm." the device will not be returned.This is not a revision of one or more implants.Patient is not part of a clinical study.Event date (b)(6) 2018.
Additional Manufacturer Narrative
Additional information received 06august2018: 12 july 2018 -- device sent to le locle for eval under fedex (b)(4) on 12 july 2018.19jul2018 sample received at le locle, 18jul2018.Patient information: n/a (not provided).No surgical delay reported.Natus completed their investigation on 04august2018.Investigation results included the following: investigation summary: the customer reported: as reported by the ous affiliate, an eds iii was leaking.Another was used to complete the procedure.There were no reports of delay or patient harm.The investigation of the eds did confirm the problem reported by the customer.The lot number is 151701, product code 82-1730.Methods/evaluation results: inspection of actual device.Complaint history review.Device history record.The eds iii was visually inspected, the needle free injection/sampling site was broken, this connector is a fixed connector and does not unscrew.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.A search for relative complaint for the same issue with the same product code and lot number for the last year revealed one other issues.Complaint (b)(4) device is not returned complaint can not be confirmed.Review of the history device records for the valve, product code 82-1730, with lot 151701, conformed to the specifications when released to stock on the 30th august 2017.50 parts released to stock.Root cause category-codman : man : user error/misuse/off label use.Failure code-codman : nic : external drains :functional issue : injection port : nos.Root cause description-the root cause of the problem reported by the customer is probably due to users error the needle free injection/sampling site does not unscrew.Is further corrective & preventative actions proposed? no.Document rationale for no corrective action-no corrective action is needed based on the results of the evaluation.The 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: 7625757
• Report Number: 2023988-2018-00035
• Device Sequence Number: 204512
• 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 Model Number: 82-1730
• Device Catalogue Number: 821730
• Device Lot Number: 151701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• 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: 08/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention