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
Additional Manufacturer Narrative
Investigation summary as reported by the ous affiliate a codman lumbar catheter becomes disconnected from the portas after implantation, requiring a revision.Event occurred during patient monitoring, not during implantation.Drain was removed prematurely to avoid risk of infection there were no reports of delay or patient harm.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.Investigation methods/evaluation results 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.Root cause category undetermined: insufficient information.Failure code codman: product analysis device not returned.Root cause description 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.No further corrective and preventative actions proposed.Document rationale for no corrective action no corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.This complaint is now deemed closed.
Event or Problem Description
As reported on a spreadsheet received from integra on 26february2018, a codman lumbar catheter becomes disconnected from the portas after implantation, requiring a revision.Event occurred during patient monitoring, not during implantation.Drain was removed prematurely to avoid risk of infection there were no reports of delay or patient harm.This is one of three incidents reported at the facility (same patient).The other two mdr#s are 2023988-2018-00006 and 2023988-2018-00007.Additional information: 09feb2018: additional information requested: a questionnaire from the department of health- therapeutic goods administration was requested to be completed and returned within seven days.On 4feb2018: the device is not being returned.On 15feb2018: additional info received: yes, the drains were removed and revised after implantation.Issue did not occur during implantation.

• 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: 7336342
• Report Number: 2023988-2018-00008
• Device Sequence Number: 3869
• 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
• Report Date (Section B): 03/13/2018

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: 821707
• Device Lot Number: H10730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention