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

Model Number G24237

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, the balloon was deflating (losing saline) with a visible decrease in balloon volume.It is not known how the procedure was completed after this difficulty.The complaint device is not available for physical evaluation.It was discarded by the user facility.No adverse effects to the patient have been reported as a result of this alleged product malfunction.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: section c.Event summary: it is reported during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, the balloon was deflating (losing saline) with a visible decrease in balloon volume.It is not known how the procedure was completed after this difficulty.No adverse effects to the patient have been reported as a result of this alleged product malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examinations were performed.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.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.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that a definitive cause for this event could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

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
• MDR Report Key: 10361318
• MDR Text Key: 201599524
• Report Number: 1820334-2020-01416
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)221017(10)10089113
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10089113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1