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	Insufficient Information (4580)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Investigation ¿ evaluation it was reported that a cook bakri postpartum balloon with rapid instillation components leaked.The device was placed by the obstetrics (ob) physician for uterine bleeding and was inflated with 240 ml of normal saline.One iodine soaked vaginal pack was also placed.Later that day, the vaginal packing and bakri were removed.During removal of the bakri, about 10 ml of fluid was removed from the balloon; however, resistance was met and no additional fluid could be removed.The bakri was gently pulled and was successfully removed without difficulty.It was noted that the bedding under the patient was saturated with clear and light pink drainage.After removal, reinflation of the bakri balloon was attempted, and a small hole was found in the balloon.No adverse effects were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was 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 dhr for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field cook also reviewed product labeling.The ifu, "t_j-sosr_rev4 bakri postpartum balloon¿, 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.Cook will continue to monitor for similar complaints.Per the 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
It was reported that a cook bakri postpartum balloon with rapid instillation components leaked.The device was placed by the obstetrics (ob) physician for uterine bleeding and was inflated with 240 ml of normal saline.One iodine soaked vaginal pack was also placed.Later that day, the vaginal packing and bakri were removed.During removal of the bakri, about 10 ml of fluid was removed from the balloon; however, resistance was met and no additional fluid could be removed.The bakri was gently pulled and was successfully removed without difficulty.It was noted that the bedding under the patient was saturated with clear and light pink drainage.After removal, reinflation of the bakri balloon was attempted, and a small hole was found in the balloon.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• 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: 20568147
• Report Number: 1820334-2024-01426
• Device Sequence Number: 7532220
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250831(10)14935418
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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 Sex: Female
• Patient Weight: 79 KG
• Patient Race: White