MAUDE Adverse Event Report: MEDCOMP 2.6FX50CM DL LMN VASCU-PICC; VASCU-PICC INFUSION CATHETER

Model Number	MR17022601
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Catheter exchange was attempted due to leaking but stopped due to retained line.Fractured line removed by interventional radiology.New line placed.

• Brand Name: 2.6FX50CM DL LMN VASCU-PICC
• Common Device Name: VASCU-PICC INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6341296
• Report Number: 2518902-2017-00005
• Device Sequence Number: 1036926
• Product Code: LJS
• UDI-Device Identifier: 00884908105186
• UDI-Public: 884908105186
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

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: MR17022601
• Device Catalogue Number: MR17022601
• Device Lot Number: MCAW870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/17/2017
• 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: 18 MO
• Patient Weight: 10