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 Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

The reporter indicated that the cook bakri postpartum balloon with rapid instillation components was the device used when a patient was having a post-partum hemorrhage.The iv bag was properly spiked but the fluid would not enter into the rapid installation tubing, however, the device was able to be inflated with the syringe.There was no harm to the patient.

Manufacturer Narrative

Investigation - evaluation the cook bakri postpartum balloon with rapid installation components was not returned/received for an evaluation.The customer report of ¿spiked the iv bag properly but the fluid will not enter into the rapid installation tubing¿ could only be confirmed based on the customer¿s testimony.Based on the information available a definitive root cause could not be established.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 review of the device history record could not be performed as the device lot number was not provided.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database for similar complaints.

Manufacturer Narrative

Correction: in the first follow-up, death was inadvertently selected instead of serious injury.Changed field from death to serious injury.

• 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: 6428278
• MDR Text Key: 70687995
• Report Number: 1820334-2017-00601
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2017

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?: No
• 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?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: 08/01/2017; 08/01/2017
• Supplement Dates FDA Received: 08/09/2017; 08/10/2017
• 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