MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EDS3 CSF EXTERNAL DRAINAGE SYSTEM WITHOUT VENTRICULAR CATHETER

Model Number	82-1731
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Natus became aware of the following complaint information (b)(6) 2017: "as reported by the ous affiliate, an eds iii was leaking around the 3 way tap., post operatively.Another was used to complete the procedure.There were no reported delay or patient harm." as no further information was provided related to the patient or the specific device (such as lot number), additional information will be requested.
Additional Manufacturer Narrative
Added 29 jan 2018: corrected patient code.Information received 15 jan 2018 from codman in provided complaint report "complaints # (b)(4)" (last updated on jan 15, 2018): no reported patient/ user harm.Based on the information provided in the above mentioned report, (b)(4) has completed its investigation.The investigation included: methods: evaluation of actual device, review of complaints history, review of past capas/capa determination.Results: the eds iii was visually inspected: no defect was noted.The eds iii was leak tested no leaks were noted.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.Review of the history device records was not possible as the lot number is unknown.Prior action taken: c/a not taken.Is further corrective & preventative actions proposed? no.The complaint was not confirmed and is now deemed closed.
Additional Manufacturer Narrative
Corrected international user facility information received from codman: (b)(6).
Additional Manufacturer Narrative
Reference natus complaint# (b)(4).Follow up# 002 re-submitted today aug 02, 2023.This report was originally submitted in error on (b)(6) 2018 as follow up # 003.Corrected international user facility information received from codman: contact name: (b)(6); complainant e-mail address: (b)(6); contact phone number: (b)(6),.

• Brand Name: CODMAN EDS3 CSF EXTERNAL DRAINAGE SYSTEM WITHOUT VENTRICULAR CATHETER
• Common Device Name: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: martin dockter ; 5955 pacific center blvd.; san diego, CA 92121 ; 8582602552
• MDR Report Key: 7190561
• Report Number: 2023988-2018-00003
• Device Sequence Number: 13698171
• Product Code: JXG
• UDI-Device Identifier: 10886704040958
• UDI-Public: 10886704040958
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K172537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 82-1731
• Device Catalogue Number: 821731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 10/23/2017; Not provided
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 01/29/2018; 08/02/2023; 08/27/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown