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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the peripherally inserted central catheter (picc) line was leaking at the insertion site.When the line was removed the leak was noted at just distal to the hub.Although it was reported that the patient had no clinical signs, symptoms, or conditions, the event was reported as a serious injury that required intervention.The type of intervention was not reported.
Additional Manufacturer Narrative
Device was not available 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 leak.

• 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 ; +1(210)226-2600
• MDR Report Key: 50132455
• Report Number: 3007697249-2026-00006
• Device Sequence Number: 10528292
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058(17)271204(10)250946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: 250946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 2 LB