MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. SPLIT CATH® III; SPLIT CATH® III CATHETER

Model Number	TRAY 3216-3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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
As rn was cleaning pt's catheter before tx, both lumen tips (luers) became detached.Rn placed both tips back into catheter, proceeded with tx as normal.The catheter did stay intact during and after dialysis tx, per patient.
Additional Manufacturer Narrative
The split cath catheter was returned for evaluation with the luers in place in the extension tubing.Visual inspection revealed no obvious damage to the device.The device was further evaluated by medcomp engineering.The luers could be manually pulled out of the extension tubing with some force.Both luers were viewed under magnification and no tool marks were noted.A supplier corrective action request was issued to the contract manufacturer for this event.Relative measurements were taken of the returned device and found it to be within specification.A review of the manufacture records revealed the device was manufactured, assembled, and inspected according to specification.The inspection process includes a pull test of the extension-luer joint that would have detected any loose luers, as well as a leak test that would have detected any leaks at the extension-luer joint if they existed at the time of manufacture.Multiple tests were conducted attempting to replicate the complaint condition.Replication of the failure mode was unsuccessful.The device was implanted and in use for more than three months with no reported issues prior to this event.A root cause cannot be determined but is not likely manufacturing related.The instructions for use (ifu) contains the following precautions: *use only luer lock (threaded) connectors with this catheter.*repeated overtightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.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: SPLIT CATH® III
• Common Device Name: SPLIT CATH® III 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: 21729638
• Report Number: 2518902-2025-00016
• Device Sequence Number: 18392739
• Product Code: MSD
• UDI-Device Identifier: 00884908056303
• UDI-Public: 00884908056303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: TRAY 3216-3
• Device Catalogue Number: TRAY 3216-3
• Device Lot Number: MRKC630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 57 YR
• Patient Sex: Male