MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5FX24CM TITAN HD CATHETER; TITAN CATHETER

Model Number	THD155024
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Death
Additional Manufacturer Narrative
One 15.5f x 24cm step tip catheter was returned for evaluation.A visual examination indicated the catheter is intact except for one of the extensions.The extension with the red sleeve and clamp is cut off at an angle approximately 2mm from the hub.The extension that was cut off was not returned.The edges of the extension remaining on the hub are smooth.This points to a cut and not a tear.The report indicated the catheter was cut during a dressing change.No catheter fault was suggested.The instructions for use include the following catheter precautions.Do not use sharp instruments near the catheter extension tubing or catheter lumen.Do not use scissors to remove dressing.Exsanguination is listed as a potential complication.
Event or Problem Description
Patient was on dialysis, being treated at home.Patient was bothered by dressing, mother of patient was changing dressing and cut catheter.Patient bled to death.

• Brand Name: 15.5FX24CM TITAN HD CATHETER
• Common Device Name: TITAN CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 14829205
• Report Number: 2518902-2022-00042
• Device Sequence Number: 4794467
• Product Code: MSD
• UDI-Device Identifier: 00884908129304
• UDI-Public: 884908129304
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

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: Lay User/Patient
• Device Model Number: THD155024
• Device Catalogue Number: THD155024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown