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

Model Number Dual-Lumen Silicone

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/06/2023

Event Type  Injury  

Manufacturer Narrative

Utmd is reporting this event because the hospital staff stated that a interventional radiology was performed to remove the remaining catheter from the patient.The mgr nicu peds at user facility stated that the patient was stable and there was no known long term effects to the patient.After investigation at utmd, the returned catheter had been damaged with sharp instrument and then torn.The returned catheter was pull tested at utmd and met specifications.The ifu has cautions indicating to take care not to damage the soft silicone catheter tubing during use.(see ifu 58078 rev 022322).

Event Description

On (b)(6) 2023.The catheter broke during removal.The remaining piece remained internal and the infant subsequently had to be shipped to the higher level of care for removal.The remaining catheter was removed at another facility with interventional radiology.

• Brand Name: UMBILI-CATH
• Type of Device: 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: 16987272
• MDR Text Key: 315818567
• Report Number: 1718873-2023-00001
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: H67142735050
• UDI-Public: H67142735050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: Dual-Lumen Silicone
• Device Catalogue Number: 4273505
• Device Lot Number: 1223017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 7 DA
• Patient Weight: 2 KG