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 Break (1069)

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

Event Date 11/14/2017

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 that during an unknown procedure when proceeding to install a cook bakri postpartum balloon with rapid instillation components in the vaginal cavity it was broken.The customer replaced it with another unit.No adverse events have been reported as a result of the alleged malfunction.Requests were made for additional information regarding, how the device was broken or in what manner did it not work, clarification on if the device is available for return, and what procedure was being performed, however, the customer has not provided any further information.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications.A visual inspection and functional testing of the returned device was also conducted.One device was returned for investigation.A visual examination noted the balloon was returned with red debris inside the balloon.A leak test was performed and the device performed normally without leaks.It is unknown what the reported issue of "broken" exactly meant but a failure could not be duplicated.Based on the investigation evaluation, 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; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and noted no non-conformances likely related to the reported failure mode.A review of complaint history revealed there has been no other complaint associated with the complaint device lot number (7957424).As per the instructions for use (ifu) warnings: the maximum inflation is 500 ml.Do not overinflate the balloon.Over inflation of the balloon may result in the balloon being displaced into the vagina.A definitive root cause for the customer¿s difficulty could not be determined.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: 7236625
• MDR Text Key: 99000467
• Report Number: 1820334-2018-00214
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200601(10)7957424
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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