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

Catalog Number J-SOSR-100500

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

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, 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

As reported, the user placed a 'cook bakri postpartum balloon with rapid instillation components' into the patient body for treatment of postpartum hemorrhage.Approximately 100-200ml of normal saline was injected to inflate the balloon, it was then noted that the saline was leaking out of the balloon.The device was removed and found to be broken.The user then used other unspecified methods to treat the hemorrhage successfully.It was reported that the patient lost >500ml of blood prior to device use, and an additional >500ml following the device issue.The patient received >500ml in blood transfusion.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation as reported, the user placed a 'cook bakri postpartum balloon with rapid instillation components' into the patient body for treatment of postpartum hemorrhage.Approximately 100-200ml of normal saline was injected to inflate the balloon, it was then noted that the saline was leaking out of the balloon.The device was removed and found to be broken.The user then used other unspecified methods to treat the hemorrhage successfully.It was reported that the patient lost >500ml of blood prior to device use, and an additional >500ml following the device issue.The patient received >500ml in blood transfusion.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Personnel interviews were also conducted.The complaint device was not returned; therefore, no functional testing or visual inspections could be performed.Cook has concluded that the device was manufactured to specification.Additionally, 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 device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu) that is packaged with the device was reviewed for relevant information pertaining to the reported failure mode.Relevant information within ifu t_j-sosr_rev4 [¿bakri postpartum balloon¿] includes: precautions: ¿avoid excessive force when inserting the balloon into the uterus.¿ - information regarding device handling and manipulation was not provided.How supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the complaint reported by the customer of the balloon leaking was confirmed due to customer testimony.Based upon the available information 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.

• 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: 17491654
• MDR Text Key: 320712412
• Report Number: 1820334-2023-01050
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250920(10)14965224
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14965224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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 Outcome(s): Other
• Patient Sex: Female