MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH; PICC

Model Number	P1PIC1.4-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not avilable for examination.In-house investigation included review of device history records.The investigation indicated no evidence of manufacturing or material related issues that would have contributed to a catheter break.
Event or Problem Description
It was reported that after the peripherally inserted central catheter (picc) had been placed in the patient, the catheter snapped.The report did not indicate the catheter separation location, or if there were any interventions performed or health impacts to the patient.

• Brand Name: POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH
• Common Device Name: PICC
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: robert davis ; 5823 sebastian place; san antonio, TX 78249 ; 2102262600
• MDR Report Key: 25034412
• Report Number: 3007697249-2026-00003
• Device Sequence Number: 9039537
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058(17)270227(10)250132
• Combination Product (Y/N): N
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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
• Device Model Number: P1PIC1.4-C
• Device Lot Number: 250132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female