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

Catalog Number 131167

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 01/28/2018

Event Type  malfunction  

Event Description

Transport nurse clamped the umbilical vessel catheter (uvc) to switch the fluids for transport with a 2x2 and clamp and when she released the clamp the catheter was pierced and leaking blood.The uvc was re-clamped and removed due to leaking catheter.

• Brand Name: UMBILI-CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS INC.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 7530712
• MDR Text Key: 108806001
• Report Number: 7530712
• 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: 02/06/2018,04/13/2018

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: No Information
• Device Expiration Date: 05/15/2022
• Device Catalogue Number: 131167
• Device Lot Number: 1716600018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1