MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP; CATHETER, PERCUTANEOUS

Model Number	67005400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged male with recent cpr in emergency dept and urgent cath.When the package was opened, the device was smashed flat in a large area, midway in the tubing.Product was not used on the patient.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 10851014
• Report Number: 10851014
• Device Sequence Number: 11567473
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: (01)20705032020166(17)230831(10)17976236
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/13/2020
• Report Date (Section F): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 17976236
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 11/13/2020