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 12/21/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient required a uvc placement.On 12-21-2021, an order was placed to discontinue the use of the uvc.During removal, the catheter was severed and a surgical procedure was required to remove the remaining indwelling catheter segment.The patient tolerated the procedure well and the uvc was completely removed.The user confirmed that the securements, sutures and secureportiv adhesive, were not removed prior to the removal attempt.

Manufacturer Narrative

Utmd is reporting this event because the hospital staff stated that a surgical procedure was required to remove the severed segment of catheter tube from the patient.The hospital staff confirmed that the catheter was sutured in place and then secureportiv adhesive was applied to the catheter and sutures.The hospital staff also confirmed that neither the adhesive nor sutures were loosened or removed prior to the catheter removal attempt.The instructions for use provided with utmd's catheter state to loosen securements before adjusting the position of the catheter.

Manufacturer Narrative

Utmd is reporting this event because the hospital staff stated that a surgical procedure was required to remove the severed segment of catheter tube from the patient.The hospital staff confirmed that the catheter was sutured in place and then secureportiv adhesive was applied to the catheter and sutures.The hospital staff also confirmed that neither the adhesive nor sutures were loosened or removed prior to the catheter removal attempt.The instructions for use provided with utmd's catheter state to loosen securements before adjusting the position of the catheter.

Event Description

On (b)(6) 2021, the patient required a uvc placement.On (b)(6) 2021, an order was placed to discontinue the use of the uvc.During removal, the catheter was severed and a surgical procedure was required to remove the remaining indwelling catheter segment.The patient tolerated the procedure well and the uvc was completely removed.The user confirmed that the securements, sutures and secureportiv adhesive, were not removed prior to the removal attempt.

• 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: ryan usgaard ; 7043 south 300 west; midvale, UT 84047 ; 8015661200
• MDR Report Key: 13362322
• MDR Text Key: 285462796
• Report Number: 1718873-2022-00001
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4273505
• Device Lot Number: 1212617
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 28 WK