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 Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that during a training session, the cook bakri postpartum balloon was being filled up with water when it burst.There was no patient contact.Additional questions were asked about the particular details of the volume of water in the balloon when it burst and whether or not the balloon was laying horizontal on the table or suspended in the air during the demonstration; however, no further details have been provided at this time.

Manufacturer Narrative

Investigation ¿ evaluation: a document based investigation has been performed which included review of complaint history, the device history record, documentation, drawings, quality control data, and specifications.A visual inspection of the returned device was also conducted.One device was returned for investigation.A visual examination of the returned device noted an approximately 2 cm cut/split in the balloon material.A review of the device history record found there was one unrelated non-conformance noted for component, missing.A review of complaint history revealed this to be the only reported complaint associated to the complaint lot number 7847900.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.According to the ifu: the maximum inflation is 500 ml.Do not overinflate the balloon.Note: to ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container rather than relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.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.Based on the available information, the root cause for this complaint in unknown.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed 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
• MDR Report Key: 7116316
• MDR Text Key: 95740037
• Report Number: 1820334-2017-03755
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200420(10)7847900
• 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: 03/07/2018

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?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1