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 Problems Blood Loss (2597); No Code Available (3191)

Event Date 06/24/2017

Event Type  Injury  

Manufacturer Narrative

Event of date is estimated to be (b)(6) 2017 to (b)(6) 2017.(b)(6).

Event Description

It was reported the user facility had two significant postpartum hemorrhages at in the last 10 days (this complaint emdr# 1820334-2017-01832 and related emdr# 1820334-2017-01831).In both cases, one of the primary nurses reported there was a failure with the balloon.The reporter had told the primary nurse after the initial case, to save the device if it were to ever happen again.This was not done during the second case.Additional information received (b)(6) 2017: the user facility reported during insertion of the bakri balloon in to the uterus during a post partum hemorrhage, the balloon was unable to fill with saline using enclosed package syringe through the stopcock.The balloon had to be discarded and a second balloon inserted.The reporter stated since the first barki balloon was unable to be inflated, the patient decompensated quickly, required a blood transfusion, hysterectomy and two nights stay in the intensive care unit (icu).

Manufacturer Narrative

Investigation ¿ evaluation: the cook bakri postpartum balloon with rapid instillation components was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.The patient experienced adverse effects due to this occurrence.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.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.The device history record could not be reviewed as the lot number of this device was not provided.A review of complaint history for this product/lot number combination was not able to be reviewed without the lot number.Based on the provided information and the investigation evaluation the actual root cause is unknown and a conclusion cannot be drawn.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: 6733296
• MDR Text Key: 80699300
• Report Number: 1820334-2017-01832
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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 Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR