MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS UMBILI-CATH; UMBILICAL VESSEL CATHETER

Catalog Number	4173505
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the hard plastic hub was removed inadvertently from the silicone hub.
Additional Manufacturer Narrative
Utmd is reporting this event because the hospital staff estimated that the patient lost approximately 3ml of blood from a 500g infant.The patient did not need a blood transfusion.No product was available for return for evaluation.The silicone catheter has a ridged barbed luer hub which is friction fit into the silicone catheter.The luer hub can be pulled out of the silicone socket if excessive force and manipulation are applied.After a week of use, the nurse removed the ridged luer hub from the silicone catheter (instead of unscrewing the luer connection) and force an iv tubing luer connector into the silicone catheter socket.This unstable connection later came loose causing the blood lose.This is an isolated occurrence.

• Brand Name: UMBILI-CATH
• Common Device Name: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS; 7043 s 300 w; midvale UT 84047
• Manufacturer (Section G): UTAH MEDICAL PRODUCTS; 7043 s 300 w; midvale UT 84047
• Manufacturer Contact: ben shirley ; 7043 s 300 w; midvale, UT 84047 ; 8015661200
• MDR Report Key: 22020539
• Report Number: 1718873-2025-00001
• Device Sequence Number: 8733964
• Product Code: FOS
• UDI-Device Identifier: H67141735050
• UDI-Public: H67141735050
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K940953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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 Catalogue Number: 4173505
• Device Lot Number: 1241222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Other
• Patient Sex: Unknown
• Patient Weight: 1 KG