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

Model Number N/A

Device Problems Inflation Problem (1310); Fitting Problem (2183)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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.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

As reported, unable to secure the connector from the syringe to the dual check valve on a cook bakri postpartum balloon with rapid instillation components.When the plunger in syringe was pulled, normal saline would not flow into syringe.There was a slight delay in patient care due to this malfunction.A second same device was obtained and it worked perfectly.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

Additional information was received 09mar2023: prior to use of the complaint device the patient received uterotonics, pitocin infusion was increased, 800 mcg of rectal misoprostol, 250 mcg og im hemabate x1, and 1000mg of tranexamic acic x 1.While attempting to connect the syringe during placement, the connector from the syringe to the dual check valve was unable to be secured.The total estimated blood loos was 800ml, but the estimated blood loss prior to the device issue was not recorded.The patient was hemodynamically stable, and received 1 unit of packed red blood cells (prbcs) on 14feb2023.No other adverse effects were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected information: b1, h1, h6 (annex e, annex f) additional information: b2, b5, d4,d9, h4 h3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event description as reported, the cook bakri postpartum balloon with rapid instillation components was used to treat postpartum hemorrhage.Prior to use of the complaint device the patient received uterotonics, pitocin infusion was increased, 800 mcg of rectal misoprostol, 250 mcg og im hemabate x1, and 1000mg of tranexamic acic x 1.While attempting to connect the syringe during placement, the connector from the syringe to the dual check valve was unable to be secured.When the plunger of the syringe was pulled, saline would not flow into the syringe.Another new bakri balloon was used to achieve hemostasis.The total estimated blood loos was 800ml, but the estimated blood loss prior to the device issue was not recorded.The patient was hemodynamically stable, and received 1 unit prbcs (b)(6) 2023.No other adverse effects were reported.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device were conducted during investigation.One cook bakri postpartum balloon with rapid instillation components was returned in an open box.The check valve appeared to have had a syringe broken off in it.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.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the most probable cause of the reported 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: 16505321
• MDR Text Key: 310961956
• Report Number: 1820334-2023-00236
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)260112(10)15162275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• 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: 15162275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Female