MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. UTAH MEDICAL PRODUCTS UMBILI-CATH; CATHETER, UMBILICAL ARTERY

Model Number 4173505

Device Problems Break (1069); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/10/2020

Event Type  Injury  

Event Description

Physician attempting to remove umbilical catheter ((b)(6) medical products) in nicu patient, felt a pop and then noted bleeding at the site.Catheter appeared to have broken at the point of insertion requiring pressure for blood loss.Physician visualized that the distal end of he catheter was completely detached.Bleeding was stopped quickly.Vital signs remained stable.Transport called emergently.Baby transported via flight to chop for catheter removal in interventional radiology.Remained at chop for care post-catheter removal.Fda safety report id# (b)(4).

• Brand Name: UTAH MEDICAL PRODUCTS UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC. ; midvale UT 84047
• MDR Report Key: 10740100
• MDR Text Key: 213467897
• Report Number: MW5097465
• Device Sequence Number: 1
• Product Code: FOS
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4173505
• Device Lot Number: 1192645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 DA
• Patient Weight: 3