MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	P1PIC1.4-C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Picc line found to be leaking during line insertion.Unable to flush through and reproduce this as the line has clotted.

• Brand Name: NA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 17764259
• Report Number: 17764259
• Device Sequence Number: 15119442
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023
• Report Date (Section F): 06/06/2023

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: P1PIC1.4-C
• Device Lot Number: (10)230088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 06/06/2023