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

Catalog Number J-SOSR-100500

Device Problem Material Rupture (1546)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that a 'cook bakri postpartum balloon with rapid instillation components' was leaking.A patient required a bakri balloon for treatment of postpartum hemorrhage with an estimated blood loss of 800ml following delivery.The device was placed and 300ml of normal saline was injected to inflate the balloon.During inflation, it was noted that the balloon was leaking.The user attempted to reposition the device and the balloon ruptured.A new 'bakri' device was used to complete the procedure.The patient lost an additional 100ml following the device issue.No blood transfusions were required.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 additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

E1: customer phone = (b)(6).E3: customer 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

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 or unavailable.Summary of event: it was reported that a 'cook bakri postpartum balloon with rapid instillation components' was leaking.A patient required a bakri balloon for treatment of postpartum hemorrhage with an estimated blood loss of 800ml following delivery.The device was placed and 300ml of normal saline was injected to inflate the balloon.During inflation, it was noted that the balloon was leaking.The user attempted to reposition the device and the balloon ruptured.A new 'bakri' device was used to complete the procedure.The patient lost an additional 100ml following the device issue.No blood transfusions were required.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 additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found no related non-conformances reported for lot 15044719.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot 15044719.Because there are 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 field.Review of the device history record, complaint history, quality control documents, and device failure analysis provides evidence that the device was manufactured to specification.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." visual inspection of the returned complaint device was also conducted.One, used, 'cook bakri postpartum balloon with rapid instillation components' was returned for investigation.Visual examination noted that the balloon material was ruptured.The complaint was confirmed based on customer testimony and evaluation of the returned device.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: 17576956
• MDR Text Key: 321531928
• Report Number: 1820334-2023-01111
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)251031(10)15044719
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 15044719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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