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

Catalog Number J-SOSR-100500

Device Problem Inflation Problem (1310)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/19/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k170622.(b)(4).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 the facility had a defective bakri balloon over last weekend.The doctor was unable to instill/inflate with fluid.Additional information has been requested regarding the patient, device and event.At the time of the report, no additional information has been forthcoming.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.No photographs or imaging was provided for review.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data, and trends.A review of the device history record for lot # 9161183 found there were no non-conformances detected.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 9161183.The instructions for use (ifu) states the following in consideration of the reported failure mode: instructions: using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.No product has been returned for evaluation.The investigation found there were no other complaints related to this lot number.Based on the information available, a definitive conclusion could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 event information received since the last report was submitted.

Event Description

Clarified information: it was reported that during a tamponade procedure using a cook bakri postpartum balloon with rapid instillation components, the physician was unable to instill any fluid into the balloon to inflate it.The physician used normal saline, and the tubing provided in the device package to attempt to fill the balloon.A second cook bakri postpartum balloon with rapid instillation components was used to complete the procedure, and it is reported that it "worked fine." no adverse events have been reported as a result of the alleged malfunction.No additional patient specific details are available according to the customer.

• 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: 8306625
• MDR Text Key: 136275258
• Report Number: 1820334-2019-00204
• 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,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 9161183
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE