MAUDE Adverse Event Report: MEDCOMP 7F X 90CM DBL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010721
Medical Device Problem Codes	Difficult to Flush (1251); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned and no photographs were provided.Without an evaluation of the complained device we cannot determine the root cause of the issue reported.The report indicated checking the catheter "due to occlusion" and the catheter "erupted".The instructions for use state the following: "excessive force should not be used to flush an obstructed lumen.Central venous access catheters may become occluded due to clotting." flushing against an occlusion by have contributed to the incident.
Event or Problem Description
The nurse was checking the arterial lumen of the central venous catheter for possible use of a thrombolytic drug due to occlusion.While flushing the arterial lumen with a 10cc saline syringe, the lumen past the "y" section erupted.The rupture was sealed with a transparent polyurethane membrane (opsite) the catheter was replaced the following day.

• Brand Name: 7F X 90CM DBL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9086333
• Report Number: 2518902-2019-00060
• Device Sequence Number: 2592728
• Product Code: LJS
• UDI-Device Identifier: 00884908084283
• UDI-Public: 884908084283
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/19/2019

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: 05/07/2024
• Device Model Number: MR28010721
• Device Catalogue Number: MR28010721
• Device Lot Number: MNKR550
• 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: Not provided
• Initial Report FDA Received Date: 09/19/2019
• 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