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

Model Number DUAL-LUMEN SILICONE

Device Problem Break (1069)

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

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Extremely premature infant delivered at (b)(6), intubated in the delivery room and admitted to nicu.A 3.5fr double-lumen umbilical venous catheter (uvc) was placed.Following an x-ray to determine appropriate placement, the neonatal nurse practitioner (nnp) gave an order to pull the uvc back 0.5cm.When the rn gently pulled back on the uvc, it reportedly snapped in half.The portion remaining in the infant was held until the nnp could successfully remove it.Staff reported the catheter broke below the suture line.Insertion distance - 6.Line was secured by suture.Nicu manager reported the break was below the suture line and didn't appear to be caused by the suture.

• 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: 8806988
• MDR Text Key: 151584701
• Report Number: 8806988
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUAL-LUMEN SILICONE
• Device Catalogue Number: 4273505
• Device Lot Number: 1182062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA