MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN LUMBAR DRAINAGE CATHETER KIT II; EXTERNAL DRAINAGE CATHETER

Model Number	82-1707
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on the spreadsheet received by natus on 14feb2018, a codman lumbar catheter easily becomes disconnected from the portas as it is not connected by luer lock.This event occured after implant; the patient had no symptoms prior to the separation, but the device was revised.There were no reports of delay or patient harm.Customer is concerned of increased of spinal cord infection due to loss of asepsis as well as risk of loss of cerebro spinal fluid causing significant neurological complications.No more information is available.Additional information: device will not be returned.A questionnaire from the department of health - therapeutic goods administration was requested to be completed and returned within seven days.On 15feb2018 additional info received: yes, the drains were removed and revised after implantation.Issue did not occur during implantation.
Additional Manufacturer Narrative
Natus has completed their investigation.The results forwarded by codman on 16march2018 (complaints # (b)(4)) included the referenced: 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 the device history record found no 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 found two similar reported complaints against this product and lot code combination; however, neither of them were confirmed.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.This complaint is now deemed closed, should the device be returned or if additional information becomes available the complaint may be reopened.

• Brand Name: CODMAN LUMBAR DRAINAGE CATHETER KIT II
• Common Device Name: EXTERNAL DRAINAGE CATHETER
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7328706
• Report Number: 2023988-2018-00006
• Device Sequence Number: 13480107
• Product Code: JXG
• UDI-Device Identifier: 10886704040811
• UDI-Public: 10886704040811
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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
• Device Expiration Date: 10/31/2021
• Device Model Number: 82-1707
• Device Catalogue Number: 821738
• Device Lot Number: H10730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 03/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention