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

Catalog Number J-SOS-100500

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The complainant reported that the physician injected 300ml saline into the balloon and found that the liquid was leaking from the vagina.It was noted the balloon had been broken; the balloon was split longitudinally.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 VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7222754
• MDR Text Key: 98973228
• Report Number: 1820334-2018-00281
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)171229(10)NS5544819
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

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?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2014
• 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 Age: 27 YR
• Patient Weight: 65