MAUDE Adverse Event Report: MEDCOMP 15.5FX28CM PC TITAN CATHETER

Model Number	THD155228E.
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the incident remains implanted in the patient and in use.No evaluation of the device can be performed.A review of the manufacture records for the lot reported was conducted and revealed the device was manufactured according to specification.The device length of implantation prior to the incident is unknown.Without an evaluation of the device the investigation cannot determine if the failure was related to the manufacturing process.It is unlikely due to the device having been in use and continues to be used for dialysis treatments with no reported problems.It is possible the connection was not fully secured.Included in the instructions for use are the following.Precaution: to prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.Warning: in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
Event or Problem Description
Patient was connected as usual to the dialysis machine.Within a few minutes, patient notified the nurse of some blood present.Another 10 minutes and it was noticed that the connection to the venous branch of the catheter to the bloodline was leaking.The dialysis machine was stopped and the venous luer was tightened.The arterial branch was checked and found to be conforming.

• Brand Name: 15.5FX28CM PC TITAN CATHETER
• Common Device Name: TITAN CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9097797
• Report Number: 2518902-2019-00061
• Device Sequence Number: 14162288
• Product Code: MSD
• UDI-Device Identifier: 00884908053272
• UDI-Public: 884908053272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K994105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: THD155228E.
• Device Catalogue Number: THD155228E.
• Device Lot Number: MKAH320
• 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: 09/05/2019
• Initial Report FDA Received Date: 09/20/2019
• 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
• Patient Weight: 83