MAUDE Adverse Event Report: COOK INCORPORATED BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; INTRAUTERINE TAMPONADE BALLOON

Model Number 624237

Device Problems Leak/Splash (1354); Defective Component (2292); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

The first bakri was defective.The physician was not able to withdraw from the balloon.A second bakri was attempted and tested prior to placement.When the bakri was placed and the physician was closing the uterine incision fluid was coming up through the incision.The bakri was removed and noted to be completely torn on one side.A third bakri was placed and functioned appropriately.Patient was taken to recovery in stable condition.No untoward patient effects.

• Brand Name: BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10725934
• MDR Text Key: 212721803
• Report Number: 10725934
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 624237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 13382528
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA