MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. BT-CATH BALLOON TAMPONADE CATHETER; INTRAUTERINE TAMPONADE BALLOON

Model Number BTC-EST

Device Problems Defective Component (2292); Material Deformation (2976)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

The following report was submitted by the land d manager: a few weeks ago we had a postpartum hemorrhage and the team wanted to use the utah balloon/uterine tamponade device.They were unable to get it to work successfully.Eventually they got one to work and the patient was stabilized.The clinical nurse educator subsequently ran a simulation training which include the use of this product.When they opened the utah balloon device they noticed one of the connection pieces was defective and they were unable to get it to work correctly.Additional comments from (b)(6), lead quality nurse consultant: the defect exists in the luer lock connector on the tubing with a spike on the opposite end.The locking device on the male end piece is warped and is not round: therefore, it is unable to accept a female connection.Product defect called into utah medical on 12/16/2019.Fda safety report id # (b)(4).

• Brand Name: BT-CATH BALLOON TAMPONADE CATHETER
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; midvale UT 84047
• MDR Report Key: 9495649
• MDR Text Key: 172409051
• Report Number: MW5091753
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BTC-EST
• Device Lot Number: 1191599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1