MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EXTERNAL DRAINAGE VENTRICULAR CATHETER SET; EXTERNAL DRAINAGE SYSTEM

Model Number	82-1705
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Added 16 jan 2017: natus has completed their initial investigation as the results were forwarded by codman 15 jan 2018 to natus on "complaints (b)(4)".Methods: review of device history records review of complaints history complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found not discrepancies when the device was released to stock.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.No further action is required.Trends will be monitored for this or similar complaints.
Event or Problem Description
As reported 23 oct 2017 by codman to natus: "as reported by the ous affiliate, a codman external drainage catheter set leaked at the catheter connections.No report of permanent consequences to the patient." additional information taken from "complaints (b)(4)" complaint record received from codman by natus on 15 jan 2018: "was there surgical delay reported? no" "is this a revision of one or more implants? no" device indicated as available for return.Device received at decontamination laboratory in (b)(6) on 17 nov 2017.
Additional Manufacturer Narrative
Natus completed their investigation.The results forwarded from codman on 05april2018 (complaint # (b)(4)) included the referenced: methods: evaluation of actual device: review of complaints history/trend analysis.Review of past capas/capa determination.Results: two luer fittings from product code 82-1705, component number 165-1056-51 were evaluated for a complaint of a crack in the connector.It is the understanding of the investigator that the component that was reported to have a crack and the replacement component, were both sent back for analysis.Both luer fittings were connected to a 60 cc syringe filled with distilled water and pressurized.A crack was noted along the parting line of one of the luer fittings.The crack was difficult to detect as it rested on a parting line of the plastic component.The second luer fitting showed no signs of a crack.The complaint for a crack in the luer fitting is confirmed.However, based on the information provided, root cause could not be determined.A review of complaint records for the previous 12 months did not identify any confirmed similar complaints for this lot and product code combination.No further action is required.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: the complaint for a crack in the luer fitting is confirmed.However, based on the information provided, root cause could not be determined.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 EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
• Common Device Name: EXTERNAL DRAINAGE SYSTEM
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7198052
• Report Number: 2023988-2018-00004
• Device Sequence Number: 1274837
• Product Code: JXG
• UDI-Device Identifier: 10886704040798
• UDI-Public: 10886704040798
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• Operator of Device: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: 82-1705
• Device Catalogue Number: 821705
• Device Lot Number: H69022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 04/05/2018
• Patient Sequence Number: 1