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

Model Number 3.5

Device Problems Break (1069); Entrapment of Device (1212); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2016

Event Type  malfunction  

Event Description

I was called to the bedside as the charge rn to look at a uac that was leaking from the umbilicus.After flushing the line again and witnessing the leaking, i called the dr to troubleshoot the uac.After flushing the line, he tried to gently pull the line out a little bit and it snapped in half.We immediately tried to retrieve the broken catheter with hemostats but he was unable to grasp it and pulled back into the vessel where it was unable to be visualized.We notified the dr of the broken catheter and he ordered an x-ray to view the location of the catheter and came to the bedside.He did an emergency cutdown of the umbilicus and removal of the catheter.He was able to remove the 11cm of catheter from the baby intact.The baby remained stable throughout the next shift.There were no complications.Umbilical incision intact without redness or drainage.Umbilical catheter 3.5 lot # 1152069.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale, UT 84047
• MDR Report Key: 5758158
• MDR Text Key: 48436582
• Report Number: 5758158
• 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: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 3.5
• Device Lot Number: 1152069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2016
• 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
• Patient Outcome(s): Other