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 Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

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 a female patient was being treated for postpartum hemorrhage.The cook bakri postpartum balloon with rapid instillation components had been positioned through the patient¿s cervix.When the syringe was attached to the device port, the operator was unable to deliver fluid through the port.The product was withdrawn and replaced with another bakri unit, which operated as expected.There were no adverse consequences reported to the patient as a result of this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, 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 functional test was performed.Water was inserted into the balloon, the balloon inflated fine.No leaks were noted.The sideport lumen was flushed without difficulty.The extension tube flushed without issue.The customer¿s difficulty of being unable to deliver fluid through the port could not be recreated.The device appears to function as intended during the evaluation.The device history record was reviewed and there were no non-conformances noted.A review of complaint history revealed no other complaints associated with the complaint device lot number.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.Per the ifu, upon removal from the package, inspect the product to ensure no damage has occurred.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.A definitive cause for the customer¿s difficulty cannot be determined.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: 7281500
• MDR Text Key: 100542502
• Report Number: 1820334-2018-00215
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200809(10)8129738
• 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
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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