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	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a c- section a bakri placement was attempted but staff was unable to draw back fluid from the bag into the syringe to fill the balloon.Multiple staff troubleshooted with no success.Eventually another bakri was opened and placed without incidence.

• Brand Name: BAKRI
• Common Device Name: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 23989297
• Report Number: 23989297
• Device Sequence Number: 13308055
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)270826(30)1(10)16222962
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/10/2025
• Report Date (Section F): 11/10/2025

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
• Operator of Device: Other
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 16222962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/10/2025