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

Lot Number	250584
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During peripherally inserted central catheter line insertion attempt using 1.4 french picc line ( lot#250584 expiration 2027-08-07) catheter separated/broke while hub was being removed.

• Brand Name: FOOTPRINT PERIPHERALLY INSERTED CENTRAL CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.
• MDR Report Key: 25209174
• Report Number: MW5188369
• Device Sequence Number: 10355002
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Lot Number: 250584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown