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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 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 or that a death or serious injury occurred; nor is it admission 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 Description

As reported, during a cesarean section, a cook bakri postpartum balloon with rapid instillation components was placed inside patient in response to massive postoperative bleeding, when the balloon leaked from a pinhole.The device inflated with air prior to use and it functioned normally.The balloon was placed into the uterine cavity and was inflated with 250ml water, however the user discovered insufficient tension.The balloon was removed and a pinhole leak on the left side of the balloon was detected.Another same type device to complete the procedure.According to the initial reporter, a suture needle was used at the same time as the device in question.The total estimated blood loss was 720ml, with 620ml occurring before device use and an additional 100ml afterwards.No blood transfusions were required.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation as reported, during a cesarean section, a cook bakri postpartum balloon with rapid instillation components was placed inside patient in response to massive postoperative bleeding, when the balloon leaked from a pinhole.The device inflated with air prior to use and it functioned normally.The balloon was placed into the uterine cavity and was inflated with 250ml water, however the user discovered insufficient tension.The balloon was removed and a pinhole leak on the left side of the balloon was detected.Another same type device to complete the procedure.According to the initial reporter, a suture needle was used at the same time as the device in question.The total estimated blood loss was 720ml, with 620ml occurring before device use and an additional 100ml afterwards.No blood transfusions were required.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device were conducted.The complaint device was returned to cook for evaluation.A small tear in the balloon material was observed under magnification.No tool marks were visible in the material.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 revealed no recorded non-conformances relevant to the failure mode.A database search identified two other complaints associated with the reported device lot.The information provided upon review of the device history record, complaint history, quality control documents, and device failure analysis does not indicate that the device was manufactured out of specification and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_j-sosr_rev4 ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: warnings "the balloon should be inflated with sterile liquid such as sterile water, sterile saline, or lactated ringers solution.The balloon should never be inflated with air, carbon dioxide or any other gas." instructions for use "warning: always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any other gas." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive cause of the event could not be determined from the available information.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 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
• Type of Device: 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: 18699150
• MDR Text Key: 336399372
• Report Number: 1820334-2024-00217
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 15129344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 68 KG