MAUDE Adverse Event Report: TERUMO CORPORATION NAVICROSS; CATHETER, PERCUTANEOUS

Model Number	NC18151
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of catheter peeled off outside of pt.Incident reported, credit issued.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 20321179
• Report Number: 20321179
• Device Sequence Number: 18167565
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: (01)04987892077319
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024
• Report Date (Section F): 06/06/2024

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: Health Professional
• Device Model Number: NC18151
• Device Catalogue Number: PN*NA18153H
• Device Lot Number: 231013
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/06/2024