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

Model Number	82-1731
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on an excel spreadsheet received from codman "an edsiii was leaking at the 3 way stopcock.The drain was changed immediately.There were no reports of delay or patient harm".Additional information was requested.
Additional Manufacturer Narrative
Additional information received on 30july2018: 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.Natus completed their investigation on 30july2018.The investsigation results are as follows: investigation summary: the customer reported: as reported by the ous affiliate, a edsiii was leaking at the 3 way stopcock.The drain was changed immediately.There were no reports of delay or patient harm.An eds was returned for evaluation (without collection bag), to codman switzerland.The investigation of the eds did confirm the problem reported by the customer.The lot number is unknown, product code 82-1731.Investigation methods/evaluation results the eds iii was visually inspected, a crack in the plastic of the patient line stop cock was found.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 was not possible as the lot number is unknown review of the history device records was not possible as the lot number is unknown.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.Root cause category-codman : man : user error/misuse/off label use.Failure code-codman : nic : external drains : broken: base : stopcock.Root cause description -the root cause of the problem reported by the customer is probably due to over tightening.As noted in the ifu connectors should be finger tightened only.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.This complaint is now deemed closed.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: 1.Adverse event and product problem.2.Required intervention tp prevent permanent impairement/ damage (devices).

• Brand Name: CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM
• Common Device Name: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 328 paramount drive; raynham MA 02767
• MDR Report Key: 7480889
• Report Number: 2023988-2018-00018
• Device Sequence Number: 16498138
• Product Code: JXG
• UDI-Device Identifier: 10886704040958
• UDI-Public: 10886704040958
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 05/02/2018

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: Other Health Care Professional
• Device Model Number: 82-1731
• Device Catalogue Number: 821731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 04/09/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 07/30/2018; 07/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention