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

Catalog Number 4273505

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2024

Event Type  Injury  

Event Description

On 1/18/2024, catheter broke during removal by physician assistant.The remaining catheter was removed with sub xyphoid surgical re-entry.

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
• Type of Device: 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
• MDR Text Key: 335022564
• Report Number: 1718873-2024-00001
• Device Sequence Number: 1
• Product Code: FOS
• 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: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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