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

Model Number	Dual-Lumen Silicone
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 16987272
• Report Number: 1718873-2023-00001
• Device Sequence Number: 6791002
• Product Code: FOS
• UDI-Device Identifier: H67142735050
• UDI-Public: H67142735050
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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 Age: 7 DA
• Patient Sex: Unknown
• Patient Weight: 2 KG