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

Catalog Number	4275005
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Utmd is reporting this event because the hospital staff stated that a surgery was performed to remove the remaining catheter segment from the patient.The clinical nurse manager stated the patient was not harmed.After investigation at utmd, the returned catheter had been damaged with an instrument just below the suture securing it and then torn.The returned catheter was tensile strength tested at utmd and met specifications.The ifu has precautions to take care not damage the soft silicone catheter during use.(see ifu 58078 rev.022322).
Event or Problem Description
The surgeon was consulted due to oozing around the umbilical cord that would not correct with any intervention.While removing 5fr double lumen umbilical catheter it broke, and 3 cm remained in the patient's umbilicus.Patient required a trip to the or to remove retained uvc that had broken off when peds surgery had tried to remove it.Incidental finding if a urachal remnant was found by surgeon.This was cause of difficulties with uvc and uac placements and possibly reason why uvc broke when peds surgery tried to remove it.The remnant was discarded, but the remaining sample is available for evaluation.

• Brand Name: UMBILI-CATH
• Common Device Name: UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• Manufacturer (Section G): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• Manufacturer Contact: ben shirley ; 7043 south 300 west; midvale, UT 84047 ; 8015661200
• MDR Report Key: 23499913
• Report Number: 1718873-2025-00003
• Device Sequence Number: 8973705
• Product Code: FOS
• UDI-Device Identifier: H67142750050
• UDI-Public: H67142750050
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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
• Device Catalogue Number: 4275005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown