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 Known Impact Or Consequence To Patient (2692)

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

The area representative reported the staff complained that the cook bakri postpartum balloon with rapid instillation components was malfunctioning.As reported, they could not draw into the syringe.The balloon was not filling correctly.This issue did not cause or contribute to any additional procedures.According to the initial reporter, there was no harm to the patient due to this occurrence.Additional event information has been requested.At the time of this report, the requested information has not yet been provided.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned devices was conducted.The investigation also included review of complaint history, the device history record, quality control data, and specifications.The complaint device was not returned for evaluation.Five (5) other devices were returned and two (2) of these were evaluated.Device #1: the syringe returned with the unopened device draws fluid correctly.A functional test was performed; 500 ml of fluid was injected into the balloon, fully inflating the balloon.The balloon was deflated; 500 ml of fluid was removed from the device with the same syringe.Device #2: the syringe returned with the unopened device draws fluid correctly.A functional test was performed; 500 ml of fluid was injected into the balloon, fully inflating the balloon.The balloon was deflated; 500 ml of fluid was removed from the device with the same syringe.The difficulty the customer experienced with the complaint device could not be recreated with the two devices that were returned unopened for investigation.The device history record was reviewed and noted one nonconformance issue found during manufacturing.This was related to foreign matter, loose found in packaging of two devices.Both of these items were reworked.A review of complaint history revealed there has been no other complaint associated with the complaint device lot number 8082885.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.Based on the provided information, a likely root cause could be attributed to user technique.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: 6944564
• MDR Text Key: 90178503
• Report Number: 1820334-2017-03571
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200721(10)8082885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/03/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/13/2018
• Date Device Manufactured: 07/21/2017
• 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
• Patient Outcome(s): Other