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

Model Number 4273505

Device Problem Leak/Splash (1354)

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

Event Date 12/23/2017

Event Type  malfunction  

Event Description

Male infant delivered at 26wk/1day via vaginal delivery w/ apgar's 2/6.Umbilical venous catheter (uvc) and umbilical arterial catheter (uac) both placed after delivery.Uvc was a 3.5 fr double lumen.It was secured with suture but cm marking is not provided to this reporter and not available in patient's emr.Lateral x-ray showed the uvc to be high.The uvc was then retracted by 0.5 cm per md order.Uac removed.During care, the rn assessed the umbilicus area to be wet.The nnp was called to the bedside.It was determined that the catheter was leaking.The uvc had remained in position from the previous repositioning on day 2.According to the care rn, staff were unable to determine where the uvc was leaking.Tubing to the uvc had been changed 1 hr earlier and no leaking was noted at that time.No clamps were in use that could have contributed to leaking.The rn reported the uvc remained sutured but did not appear excessively tight.The uvc was removed per nnp order.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047 1048
• MDR Report Key: 7181717
• MDR Text Key: 96973103
• Report Number: 7181717
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2017

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: 4273505
• Device Lot Number: 11663555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE PATIENT HAD A UAC IN PLACE UP UNTIL 1 DAY PRIO
• Patient Weight: 1