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 Leak/Splash (1354); Material Separation (1562); Component Missing (2306)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient experienced postpartum hemorrhage on (b)(6) 2017 after an unspecified procedure.A postpartum balloon with rapid instillation components was used for temporary control without any incidents to the patient.The next morning the stopcock was missing.It appeared to have been torn off and an undetermined volume of fluid had escaped from the device.The tamponade had maintained its integrity allowing no adverse effects to the patient.Additional information was provided on (b)(6) 2017 by the (b)(6) theatre, commenting that the probable cause was the stopcock had gotten tangled in the patient¿s bed clothing and ripped the device.It was noted that there was no indication that a design or process related failure mode contributed to this event.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of the specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the product was extremely bloody.The distal tip was shoved into the inflation lumen when returned.No stopcock was returned, however the device does have indentations and adhesive inside the balloon material shows the stopcock had once been attached.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Review of device history and non-conformances was not possible as the lot number was not available.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

Patient experienced post partum hemorrhage on (b)(6) 2017, bakri used without incident.Next morning the stopcock was missing, appears to have been torn off.The fluid had escaped from the device.Tamponade was maintained, no adverse effects on the patient.Packaging has been discarded, cannot identify the lot no.Product retained by theatre, to be picked up by company representative on fri 10 feb.In the completed complaint form received on 10 feb this additional information was included: on fri 10 feb the (b)(6) theatre commented that he thought the probable cause was the stopcock got tangled in the patients bedclothes and was ripped from the device.He also suggested that a one way valve on the affected part would serve as a safety precaution, so fluid couldn't escape if the same situation occurred.With the mechanism of this kind the fluid would be released only by some deliberate pressure on the device, not by incidental contact.Courier contacted to collect device on fri 10 feb.Deflated bakri was removed without incident.The product did not cause or contribute to the need for additional procedures.The complainant did not inform any adverse effect on the patient due to this occurrence.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6390709
• MDR Text Key: 69439689
• Report Number: 1820334-2017-00531
• Device Sequence Number: 1
• Product Code: KNA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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