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 Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 cook bakri postpartum balloon with rapid instillation components was used to treat postpartum hemorrhage.As reported, when they attempted to fill the bakri, they recognized that they could not fill the syringe with sterile saline, it felt like producing vacuum in the syringe.They disconnected the two way check and the three way check valve and added their own three way check valve and the problem was solved and the bakri did its job.Additional information was received on 12jul2018.A cook representative visited with the nurse that set up this device.The nurse demonstrated how they had set up the device.The nurse incorrectly put the syringe on the red end of the 3-way check valve.The red connector that comes off the tubing that is coming from the iv bag is supposed to be connected with the red end on the 3-way check valve.Additionally, it was confirmed the patient did not experience any adverse effects due to this occurrence.The instructions for use (ifu) contains information with diagrams on balloon inflation with rapid instillation components.Instructs you to hook tubing to iv bag.Shows tubing connected to iv bag.Instructs you to connect the end of the tubing to the 3-way check valve (there is red on the three-way check valve and the connecter that fastens to the check valve is also red.) instructs you to fasten stop cock to 3-way check valve.Instructs you to connect the syringe to the 3-way check valve.

Manufacturer Narrative

Method codes: 4114, device not returned.Investigation: evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.The device history records were reviewed and found there were no related conformances during the manufacturing and inspection process.A complaint history review revealed this is the only complaint associated with lot number: 7416254.The instructions for use (ifu) contains information with diagrams on balloon inflation with rapid instillation components.1) instructs you to hook tubing to iv bag.2) shows tubing connected to iv bag.3) instructs you to connect the end of the iv bag tubing to the 3-way check valve (there is red on the three-way check valve and the connecter that fastens to the check valve is also red).4) instructs you to fasten stop cock to 3-way check valve.5) instructs you to connect the syringe to the 3-way check valve.Warnings: 2.Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.The ifu contains figures demonstrating the assembly of the bakri on balloon inflation with rapid instillation components.A review of the ifu was conducted with a bakri device to ensure the figure instruction was accurate.No problems were found with the instructions and expected outcome of correct assembly of the device.The investigation determined the cause of the complaint was inadequate training.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Per the quality engineering risk assessment, no further action is required.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

The cook representative has scheduled an in service and hands on training in september 2018 with the facility team members including doctors, nurses, and midwives.

• 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: 7693384
• MDR Text Key: 114146535
• Report Number: 1820334-2018-01843
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)191103(10)7416254
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2019
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 7416254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1