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 Problem Defective Component (2292)

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

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Patient code: no known impact or consequence to patient.Device code: balloon.Component defective, which is not labeled.This event is currently under investigation.

Event Description

The balloon was defective.The patient outcome will be determined when the answers to the additional questions are received.No adverse event is know of at this time.

Manufacturer Narrative

Based on the investigation, 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 and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The (ifu) t_j-sosr_ rev.1 does not contain information regarding the failure mode.This complaint is confirmed based on the customer's testimony.Based on the provided information a definitive root cause cannot be established or reported at this time.No lot number was provided; therefore a review of no non-conformances cannot be completed at this time.If new information becomes available the complaint will be updated at that time.No lot number or serial number was provided; therefore a review of the manufacturer's database for similar complaints cannot be completed at this time.If new information becomes available the complaint will be updated at that time.

Event Description

It was reported that during the procedure, the device could not be inflated due to the inability to align the device components for connection.Another j--sosr-100500 was used to complete the procedure.

• 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 ; 8128294891
• MDR Report Key: 5789970
• MDR Text Key: 49399660
• Report Number: 1820334-2016-00614
• Device Sequence Number: 1
• Product Code: KNA
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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