MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I; INTRAUTERINE TAMPONADE BALLOON

Model Number BTC-ESY

Device Problems Loose or Intermittent Connection (1371); Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

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

Event Date 01/07/2020

Event Type  malfunction  

Event Description

This report pertains to a utah balloon which was used on a pt.Bt - balloon tamponade catheter for postpartum uterine hemorrhage with easy fill inflation systems utah medical products (b)(4), btc-esy, lot# 1191599, exp 2024-09-17.During training, i opened the package and tried to connect the clear luer lock port to the blue stop cock and no matter what i did it would not screw on.First when i opened it on the clear luer lock part, the circular tube in it was bent to the side so i had to bend it back and it still wouldn't work.The lot number 1191599 on this device is the same lot number, reported in rm# 19-61223.The luer lock is visibly defective, however, it is difficult to photograph.Fda safety report id# (b)(4).

• Brand Name: BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC. ; midvale UT 84047
• MDR Report Key: 9592607
• MDR Text Key: 175650739
• Report Number: MW5092249
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BTC-ESY
• 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