MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.5F X 90CM SGL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010911
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Facility reported patient was seen in interventional radiology for low flow vascular catheter exchange.The single lumen catheter needed to be replaced due to a crack within it.

• Brand Name: 9.5F X 90CM SGL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9495261
• Report Number: 2518902-2019-00080
• Device Sequence Number: 1854147
• Product Code: LJS
• UDI-Device Identifier: 00884908084276
• UDI-Public: 884908084276
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: MR28010911
• Device Catalogue Number: MR28010911
• Device Lot Number: MNJC780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• 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