MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS UMBILI-CATH

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 06/14/2016

Event Type  Injury  

Event Description

Iv access was needed and umbilical vein and umbilical artery catheters were placed.A chest x-ray confirmed that the umbilical vein needed to be retracted, and upon retraction the catheter broke off in the infant.

• Brand Name: UMBILI-CATH
• Type of Device: UMBILI-CATH
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS; midvale UT 84047
• MDR Report Key: 5735728
• MDR Text Key: 47826010
• Report Number: MW5062907
• Device Sequence Number: 1
• Product Code: FOS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization