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

Catalog Number	4273505
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/18/2024, catheter broke during removal by physician assistant.The remaining catheter was removed with sub xyphoid surgical re-entry.
Additional Manufacturer Narrative
Utmd is reporting this event because the hospital staff stated that a sub xyphoid surgical re-entry was performed to remove the remaining catheter from the patient.The ct surgery advanced lead at the user facility stated that the patient is doing well.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 during use.(see ifu 57078 rev 022322).

• Brand Name: UMBILI-CATH
• Common Device Name: UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC; 7043 south 300 west; midvale UT 94047
• 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: 18677307
• Report Number: 1718873-2024-00001
• Device Sequence Number: 20681394
• Product Code: FOS
• UDI-Device Identifier: H67142735050
• UDI-Public: H67142735050
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/09/2024

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: 4273505
• Device Lot Number: 1230384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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