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

Model Number G24237

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Repeat cesarean section.Bleeding from posterior placental bed.Bakri placed intra-op.Total 200cc saline placed in balloon.A "pop was heard and uterine distension palpably diminished.Bakri removed and discovered to be split along the length of the balloon.Manufacturer response for bakri baloon, bakri (per site reporter).Cook (b)(4).

• Brand Name: BAKRI
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 17939708
• MDR Text Key: 325736291
• Report Number: 17939708
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: 15143750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female