[Risk Analysis for Bakri Postpartum Balloon in Clinic]

Area of Science:

• Obstetrics and Gynecology
• Medical Device Safety
• Patient Safety

Background:

• Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality worldwide.
• The Bakri postpartum balloon is a crucial device for managing PPH.
• Ensuring the safe and effective use of medical devices is paramount.

Purpose of the Study:

• To analyze adverse events associated with the Bakri postpartum balloon.
• To identify factors contributing to these adverse events.
• To propose recommendations for improving the safety of the Bakri postpartum balloon.

Main Methods:

• Adverse event data were collected from the National Medical Device Adverse Event Monitoring Information System and the U.S. FDA MAUDE database.
• Comparative analysis of Chinese and English instructions for use was performed.
• Root causes of identified adverse events were investigated.

Main Results:

• The primary adverse events reported were balloon rupture and fluid leakage.
• Insufficient or unclear instructions were identified as a major contributing factor.
• Deficiencies in the description of surgical steps, specifically myometrial suturing and balloon filling sequence, were noted.
• Risk of balloon damage from sharp instruments during insertion was highlighted.

Conclusions:

• Improving the product's instructions for use is essential for enhancing safety.
• Enhanced training for healthcare professionals on the correct usage of the Bakri postpartum balloon is recommended.
• Strengthening adverse event monitoring systems for postpartum balloons is advised.