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

Model Number P2UVC3.5

Device Problems Break (1069); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 293250454
• Report Number: 3007697249-2022-00001
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10858778006536
• UDI-Public: (01)10858778006536(17)240204(10)220125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 DA