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

Model Number 3.5 FR & 5.0 FR

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

These two events are being reported per the asr reporting requirements under exemption number 2011004.One of the catheters was a single lumen 3.5 french silicone catheter catalog number 4173505 and 2nd catheter was a 5.0 french dual lumen catheter catalog number 4275005.Both catheters had indications that the tubing had been damaged (cut or nicked) prior to the tubing sever.In both cases the tubing segment severed from the catheter was routinely removed without patient impact.Both catheters met the tubing strength specifications when tested after return to utmd.

Event Description

This report summarizes 2 reported events which were reported over a 3 month time period.On both events, catheter tubing severed while the catheter was being removed from the patient.In both cases the segment which was severed from the catheter was removed from the patient without patient impact.

• 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 ; 8015661200
• MDR Report Key: 7229237
• MDR Text Key: 98847549
• Report Number: 1718873-2018-00001
• 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: 01/30/2018

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: 3.5 FR & 5.0 FR
• Device Catalogue Number: 4173505
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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