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

Model Number	G24237
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Repeat c-section.Bakri placed by physician.Normal saline used to fill the bakri balloon.There was a pop and blood tinged fluid exited the vagina.It was determined that the bakri had ruptured.The bakri was removed from the body without difficulty.The bakri had a straight tear or slice lengthwise down the balloon but otherwise was intact.

• Brand Name: BAKRI
• Common Device Name: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 20556748
• Report Number: 20556748
• Device Sequence Number: 19633506
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)261117(30)1(1015762624
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024
• Report Date (Section F): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 15762624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Date Report Sent to FDA: 08/05/2024