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

Model Number N/A

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

These two events are being reported per the asr reporting requirements under exemption number 2011004.Both catheters had evidence that the cause of the tubing sever was related to the application of an excessive tensile force on the catheter tubing.The tubing on both catheters was tested for tensile force.The force required to break the tubing and the tubing elongation were within specification.On catheter #1 surgical intervention was used to remove the catheter.There was no significant blood loss as a result of the tubing sever.There was no permanent impairment to a body function or damage to a body structure.On catheter #2 there was no significant blood loss.The catheter was routinely replaced without patient impact.

Event Description

This report summarizes 2 reported events.On one of these events the tubing was severed while the catheter was being removed from the patient.The tubing segment which was severed from the catheter was removed from the patient using a surgical procedure.The patient did not lose any blood as results of the tubing sever, and the nurse reporting the event indicated that this was not an adverse event.On the 2nd event the catheter tubing was severed just below the hub after about 5 hours use.The nicu clinical coordinator at the hospital stated that there was no adverse effect to the patient as a result of the tubing sever.

• Brand Name: UMBILI-CATH
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS INC.; 7043 south 300 west; midvale UT 80047
• Manufacturer Contact: ben shirley ; 7043 south 300 west; midvale, UT
• MDR Report Key: 6979584
• MDR Text Key: 91213295
• Report Number: 1718873-2017-00001
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 4275005
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1