MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOS-100500

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The following information was reported for a hemostasis procedure: the user inflated the balloon with 50ml of saline prior to patient contact and didn't find any damage in the balloon.The balloon was deflated and inserted into the patient; the balloon was inflated with approximately 150ml of saline.The bleeding stopped, but started again after approximately 2 hours so the balloon catheter was removed.The same balloon catheter was then reinserted and the balloon was inflated with approximately 120ml of saline.The cervix was pulled with forceps to perform local anesthesia and water came out with a splashing sound.The balloon catheter was removed and it was noted that the balloon had a tear that was approximately 5cm.Another device (same kind) was placed in the patient.The user noted that the balloon did not come in contact with any hard object and there was no damage on the balloon when it was inserted.There were no reported adverse effects to the patient as a result of the reported product problem.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• 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: 7224118
• MDR Text Key: 98976803
• Report Number: 1820334-2018-00284
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)180830(10)6165696
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2018

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 Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2015
• 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