MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number	G24237
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an unspecified procedure, a cook bakri postpartum balloon with rapid instillation components had a small hole.Saline solution was noted leaking out.The balloon was placed by a gynecologist when the issue was observed.The procedure was completed by using another same-like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional information has been requested but is unavailable at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Additional information received (b)(6) 2025: b5, b7 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information received (b)(6) 2025: the device was placed transvaginally for treatment of post-partum hemorrhage (pph).The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.Total estimated blood loss was 800cc; no additional blood loss was reported following the device failure.The patient did not require any blood transfusions.The device was removed and replaced with a new bakri to control the hemorrhage and complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: g1 investigation ¿ evaluation it was reported during an unspecified procedure, a cook bakri postpartum balloon with rapid instillation components had a small hole.Saline solution was noted leaking out.The balloon was placed by a gynecologist when the issue was observed.The procedure was completed by using another same-like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.The device was placed transvaginally for treatment of post-partum hemorrhage (pph).The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.Total estimated blood loss was 800cc; no additional blood loss was reported following the device failure.The patient did not require any blood transfusions.The device was removed and replaced with a new bakri to control the hemorrhage and complete the procedure.Reviews of the complaint history, device history record (dhr), device master record (dmr), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no functional testing or visual inspections could be performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no related non-conformances reported for this failure mode.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field.It was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based upon the available information, no product returned, and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified, and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Common Device Name: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 21198733
• Report Number: 1820334-2025-00084
• Device Sequence Number: 7559484
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)270108(10)15835183X
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 15835183X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/21/2025; 04/03/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/19/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 77 KG