MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOSR-100500

Device Problem Deflation Problem (1149)

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

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

(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 female patient was treated for post-partum hemorrhage using an inflated cook bakri postpartum balloon.As reported, the catheter was unable to be deflated by withdrawing water from the three-way tap.The three-way tap port was removed so the bakri could be deflated.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the cook bakri postpartum balloon with rapid instillation components was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of complaint history, the device history record, instructions for use, quality control data and specifications was conducted.The device history record was reviewed and noted there were no non-conformances associated with the complaint device lot number.A review of complaint history records revealed this complaint to be the only complaint associated to lot number 8287600.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the ifu was performed.The ifu provides the steps for using rapid installation component (ric for short, described in the report as "three-way tap").The final step shows the syringe and ric removed once inflated.The ric is a one-way apparatus to aid with faster inflation of the balloon and does not allow for deflation.The product was not returned so the functionality of the device could not be confirmed.The report indicated that fluid could not be withdrawn through the ric which is how the ric was designed to perform.The cause of the complaint is likely related to the use of the ric while attempting to deflate the balloon.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.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7286634
• MDR Text Key: 100783640
• Report Number: 1820334-2018-00456
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)201012(10)8287600
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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 Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 05/03/2018
• Date Device Manufactured: 10/12/2017
• 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