MAUDE Adverse Event Report: MEDCOMP 7F X 60CM DUAL PRO LINE CT; CENTRAL VENOUS CATHETER

Model Number	MR28037201
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.(b)(4).
Event or Problem Description
Three weeks post insertion the patient was in ct scan to have a contrast computed tomography angiography (cta) done.Upon administration of contrast, limited contrast was seen on cta.Reportedly, the power-line infiltrated.100cc of omni350 contrast was injected but an unknown amount infiltrated as some was seen on cta and some leaked around the power-line catheter.Patient required additional procedure to replace the power-line catheter.Reportedly there was no harm to the patient.

• Brand Name: 7F X 60CM DUAL PRO LINE CT
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7248894
• Report Number: 2518902-2018-00006
• Device Sequence Number: 13699806
• Product Code: LJS
• UDI-Device Identifier: 00884908034646
• UDI-Public: 884908034646
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 04/08/2019
• Device Model Number: MR28037201
• Device Catalogue Number: MR28037201
• Device Lot Number: MHMN090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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 Age: 62 YR