MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 24CM SPLIT CATH SET; SPLIT CATH® III CATHETER

Model Number	DASPC24P-XL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Protective plastic sheath inadvertently placed over the catheter during insertion.
Additional Manufacturer Narrative
The report was provided by the u.S.Food and drug administration (fda) in the form of a voluntary medwatch that was submitted to them by the user facility.The reporter elected to remain confidential making it impossible for medcomp to obtain additional information regarding the event.The details of what component was involved and the procedure used would be required for an investigation, review of manufacturing records and a risk assessment.An investigation on medcomp's part is impossible.

• Brand Name: 10F X 24CM SPLIT CATH SET
• Common Device Name: SPLIT CATH® III CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 23003250
• Report Number: 2518902-2025-00049
• Device Sequence Number: 18546554
• Product Code: MSD
• UDI-Device Identifier: 00884908181852
• UDI-Public: (01)00884908181852(17)270125(10)MRJC960
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: Health Professional
• Device Model Number: DASPC24P-XL
• Device Catalogue Number: DASPC24P-XL
• Device Lot Number: MRJC960
• 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: 09/08/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown