MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. DUAL LUMEN 3.5FR POLYURETHANE UMBILICAL CATHETER

Model Number	P2UVC3.5
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The umbilical catheter was reported to have been placed in the umbilical vein of a newborn baby.After successfully completing the course of therapy, the catheter was removed.Upon extraction, the nnp noticed that the tip appeared jagged and stretched.Concerned that the tip may have broken off in the patient, an x-ray was performed which revealed no indication of a piece of the catheter being left inside the patient.Per the hospital, no patient harm was found and no further actions were taken.
Additional Manufacturer Narrative
Investigation included review of the returned device and a sample from another lot of like product in an attempt to reproduce the failure mode.The investigation concluded that tension applied to the device during removal of the catheter against the suture caused stretching of the distal 4cm and cutting off of the last 0.5mm of the catheter.The investigation indicated no evidence of manufacturing related issues that could have contributed to the event.

• Brand Name: DUAL LUMEN 3.5FR POLYURETHANE UMBILICAL CATHETER
• Common Device Name: UMBILICAL CATHETER
• 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: 14576388
• Report Number: 3007697249-2022-00001
• Device Sequence Number: 4981656
• Product Code: FOS
• UDI-Device Identifier: 10858778006536
• UDI-Public: (01)10858778006536(17)240204(10)220125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: P2UVC3.5
• Device Lot Number: 220125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Patient Age: 5 DA
• Patient Sex: Unknown