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

Model Number N/A

Device Problem Break (1069)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

As reported, while installing a cook bakri postpartum balloon with rapid instillation components, the tip of the 50 cc syringe broke in the three-way stopcock.This failure happened twice with two like devices.A third like device was used to complete the procedure.The complainant did not report any adverse effects on the patient due to this occurrence.Additional information has been requested but is not available at this time.

Manufacturer Narrative

Initial reporter occupation: occupation: coordinator.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 Description

Additional information received 27feb2023: the two devices (cook bakri postpartum balloon with rapid instillation components) with the failure of the syringe broke in the three-way stopcock occurred with the same patient.Estimated blood loss information was not available.The patient was hemodynamically stable at the time of the failures.The patient did not require hospitalization or prolonged hospitalization due to this occurrence.The occurrence did not create the need for any medical or surgical intervention.Hemostasis was achieved when the hospital used the 3rd device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Event description: as reported, while installing a cook bakri postpartum balloon with rapid instillation components, the tip of the 50 cc syringe broke in the three-way stopcock.This failure happened twice with two like devices with the same patient.Estimated blood loss information was not available.The patient was hemodynamically stable at the time of the failures.The patient did not require hospitalization or prolonged hospitalization due to this occurrence.The occurrence did not create the need for any medical or surgical intervention.A third like device was used to complete the procedure and hemostasis was achieved.The complainant did not report any adverse effects on the patient due to this occurrence.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One cook bakri postpartum balloon with rapid instillation components was returned for evaluation.Visual inspection confirms what appears to be a syringe broken off inside the three-way stopcock.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, 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 the field.Review of the device history record, complaint history, relevant manufacturing documents, and device failure analysis does provides evidence that the device was manufactured to specification.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: 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, the most probable cause for this event 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.

• 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: 16418402
• MDR Text Key: 310347039
• Report Number: 1820334-2023-00168
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250322(10)14614658
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 14614658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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 Sex: Female