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

Model Number	THD155228E.
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device is import for export only, not sold in the us.Udi not applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Central dialysis catheter cracked at the plastic base.Rupture at the junction of the catheter branches causing air leakage into the circuit and requiring replacement of the dialysis catheter.
Additional Manufacturer Narrative
The catheter was returned for evaluation.Initially reported as a titan catheter.Lot number taken directly from the returned device shows it is a hemo-flow catheter.Visual inspection revealed the hub is cracked and the first 2 cm of the lumen appears stretched/swollen and flattened.The condition of the device strongly suggests it was exposed to a solution that is corrosive to the device material.Although it was requested, information regarding all solutions/procedures used on this device was not provided by the customer.An implanted catheter is exposed to many variables for which the manufacturer has no influence or control.These variables include but are not limited to care and maintenance of the catheter by healthcare providers and the patient, exposure to site care agents and ointments, locking solutions, and off label uses.All of which may be contributing factors to the type of failure observed.Because all of the complaints for cracked hubs on the hemo-flow catheter in the past 5 years have come from the same facility, it is determined that no further investigation is warranted at this time.Device history record analysis was performed on the catheter lot.The review showed no deviations from specifications, including amvs (authorized manufacturer variances).There were no sorting records from complaints or ncrs (non conformance reports) associated with the reported failure mode (crack on hub) found in the reviewed lots.Based on this review it was confirmed that the manufacturing process fully complied with the customer specifications.The manufacture process includes a 100% leak test.The leak test is the final manufacturing operation before quality inspection and packaging operations per product routine.If the hub, extensions or lumen of catheter has damaged such holes, ruptures, tears, or small pin holes that could cause leaks, the leak test operation can detect them.The process engineer for this product was consulted regarding any changes to the mold and gate, and he confirmed that the mold or its gate has not suffered any changes or repairs.All finished goods are leak tested as part of the standard manufacturing routine to identify any potential leakage issues.The device was in use for over 1 year prior to noticing the issue.As there have been no changes to the tooling, molds, or methods of manufacture, it can be concluded that the root cause is most likely not directly linked to the manufacturing processes.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TITAN HD
• Common Device Name: TITAN HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 23466031
• Report Number: 2518902-2025-00065
• Device Sequence Number: 21050369
• Product Code: MSD
• UDI-Device Identifier: 00884908053272
• UDI-Public: 884908053272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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: Other
• Device Model Number: THD155228E.
• Device Catalogue Number: THD155228E.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/26/2025
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 48 KG