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

Model Number	THD155024
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter was inserted on (b)(6) 2024 and needed to be exchanged on (b)(6) 2024 due to a crack in the venous lumen tubing closest to the hub.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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.
Additional Manufacturer Narrative
Received on 15.5f x 24 cm titan catheter for evaluation.A visual inspection indicated the catheter is intact with no obvious abnormalities.There are sutures wrapped and tied around the lumen between the cuff and the hub.A functional evaluation was performed.Flushing the venous blue lumen showed no leaks.When flushing the arterial red lumen, a leak was noted at the extension tubing to hub junction.There is a hole in the extension tubing that can only be seen if the tubing is bent away from the hub.Under magnification it is noted that the arterial extension tubing is torn/pulling away from the hub.A supplier corrective action request was issued to the contract manufacturer for this event.The contract manufacturer leak tested the device using a tinted liquid to facilitate the identification of the damaged area.Additionally, a picture with magnification of the damaged area, to make the damage more evident the arterial extension was bent towards the opposite direction of the venous extension.Upon visual inspection of the image, it is apparent that the extension exhibits an irregular perforation and signs of stress on the left and right sides of the periphery of the leak hole.A cross-section of the hub was performed to analyze the insertion depth of the extensions.The insertion depth of the extension tubes was to specification and the remaining extension tubing into the hub was firmly adhered.The condition of the device suggests the extension tubing was torn and did not pull out.A review of the manufacture records for the lot number reported revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.We are not able to determine the circumstances that may have led to the complaint condition, but it is not likely manufacture related.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: 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: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18835830
• Report Number: 2518902-2024-00017
• Device Sequence Number: 18006826
• Product Code: MSD
• UDI-Device Identifier: 00884908129304
• UDI-Public: 00884908129304
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K994105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 05/11/2026
• Device Model Number: THD155024
• Device Catalogue Number: THD155024
• Device Lot Number: MRAP910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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 Sex: Unknown