MAUDE Adverse Event Report: COOK INCORPORATED BAKRI; INTRAUTERINE TAMPONADE BALLOON

Model Number G24237

Patient Problems Exposure to Body Fluids (1745); Hemorrhage/Bleeding (1888); Fluid Discharge (2686)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Bakri balloon tamponade device placed by physician, ob hospitalist for uterine bleeding.Filled with 240 ml of ns per progress note with 1 iodine soaked vaginal pack in place.Later in the day physicians removed bakri balloon and vag packing.Physician removed approx 10 ml of clear fluid removed from balloon and then met resistance.Attempted to remove additional fluid from balloon.No additional fluid able to be removed.The physician gently pulled on bakri and balloon was removed without difficulty.Bedding under patient saturated with clear and light pink drainage.Bakri balloon was attempted to be re-inflated after removal and confirmed to have a small hole found in balloon.

• Brand Name: BAKRI
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 17994850
• MDR Text Key: 326394525
• Report Number: 17994850
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14935418
• 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: 09/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9855 DA
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White