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

Model Number N/A

Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2016

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 the balloon of cook bakri postpartum balloon with rapid instillation components burst when inflated.It was further reported that the catheter was contaminated as it came in contact with the secretions from the patient.The customer disposed the catheter.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No additional information has been provided regarding patient outcome.

Manufacturer Narrative

Investigation/evaluation: the complaint device was not returned; therefore, a physical examination could not be performed.Photographs were not provided.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 5996576.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6639886
• MDR Text Key: 77531428
• Report Number: 1820334-2017-01438
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)180629(10)5996576
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

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 Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 09/18/2017
• Date Device Manufactured: 06/29/2015
• 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