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 01/07/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6).E3 - occupation: agent.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 treatment for postpartum hemorrhage, after a cesarean section, a cook bakri postpartum balloon with rapid instillation components' balloon was found damaged/leaking.The patient with twin pregnancy returned to the ward after completion of the cesarean section.When the postpartum hemorrhage was approximately 500 ml, the medical staff used medication ("xin mother pei") to establish hemostasis, however the treatment effect was not significant.To control bleeding, a cook bakri postpartum balloon was used.The balloon was placed vaginally and 350ml of water was injected.Upon b-ultrasound examination, the balloon was found to be damaged/leaking.The balloon was immediately removed, replaced with a new cook balloon, and then hemostasis was achieved.Approximately 500ml of blood loss occurred before the device leaked and an additional 600ml after.No transfusions were administered.The device was not handled by or in the proximity of any metal tools.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Correction: h6 (annex g).Investigation evaluation: as reported, during a treatment for postpartum hemorrhage, after a cesarean section, a 'cook bakri postpartum balloon with rapid instillation components' balloon was found damaged/leaking.The patient with twin pregnancy returned to the ward after completion of the cesarean section.When the postpartum hemorrhage was approximately 500 ml, the medical staff used medication ("xin mother pei") to establish hemostasis, however the treatment effect was not significant.To control bleeding, a cook bakri postpartum balloon was used.The balloon was placed vaginally and 350ml of water was injected.Upon b-ultrasound examination, the balloon was found to be damaged/leaking.The balloon was immediately removed, replaced with a new cook balloon, and then hemostasis was achieved.Approximately 500ml of blood loss occurred before the device leaked and an additional 600ml after.No transfusions were administered.The device was not handled by or in the proximity of any metal tools.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.One, used, 'cook bakri postpartum balloon with rapid instillation components' was returned for investigation.The balloon was function tested by injecting water into the inflation port.The injected water was observed to then drain out of the flushing port, indicating lumen communication.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 one (1) other related complaints associated with the failure mode for the complaint device for lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire 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.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 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: 18615852
• MDR Text Key: 334222752
• Report Number: 1820334-2024-00142
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)261013(10)15706150
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 15706150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• 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 Sex: Female