MAUDE Adverse Event Report: FOOTPRINT MEDICAL , INC. UMBILICAL CATHETER 3.5FR DL; CATHETER, UMBILICAL ARTERY

Lot Number 220125

Device Problems Device Markings/Labelling Problem (2911); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  Injury  

Event Description

This is a premature infant in nicu who had an umbilical catheter.This catheter was pulled from the patient on (b)(6) 2022 after picc line placement.The umbilical catheter was stretched and curved.When it was outside the patient, the catheter was noted to have jagged edges.The neonatal nurse practitioner stated that she saw no abnormality with the umbilical catheter prior to placement.The nnp's do check lines for integrity prior to placement.Upon removal, this line was compared with a packaged catheter.The removed catheter was stretched and the markings did not match the packaged line cm markings.Fda safety report id #:(b)(4).

• Brand Name: UMBILICAL CATHETER 3.5FR DL
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL , INC.; san antonio TX 78249
• MDR Report Key: 14257490
• MDR Text Key: 290553637
• Report Number: MW5109453
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Lot Number: 220125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White