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

Model Number DUAL-LUMEN SILICONE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Plastic piece from double lumen noted to be disconnected.Tpn and lipids noted to be leaking onto white padding under line.Line immediately clamped with hemostat.Line removed and piv placed.Vanco dose given.We do have device to send back.

• 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: 14436097
• MDR Text Key: 292040259
• Report Number: 14436097
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DUAL-LUMEN SILICONE
• Device Catalogue Number: 4275005
• 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: 05/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1