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

Catalog Number J-SOSR-100500

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during the treatment of post partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the blue stop cock had to be turned on and off while filling the balloon.They stated there was some chance this was user error.No known adverse effects to the patient have been reported.Additional information has been requested.At this time, no additional information is known.A follow up report will be submitted if additional details requested are received.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported, during the treatment of post partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the blue stop cock had to be turned on and off while filling the balloon.They stated there was some chance this was user error.Investigation ¿ evaluation.A document based investigation was also performed including a review of the instructions for use and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specifications.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a database search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: balloon inflation: "with syringe", "using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock." how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.The complainant did not return the complaint device to cook for investigation.A definitive cause of the reported event could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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

No new patient or event information to report.

• 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: 9817396
• MDR Text Key: 182921490
• Report Number: 1820334-2020-00585
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1