MAUDE Adverse Event Report: BRACCO DIAGNOSTICS AUTOMATED CO2 COLON INSUFFLATOR; CT COLONOSCOPY INFUSSLATION DEVICE

Catalog Number 390301

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

Air cuff burst in pt's rectum while performing ct colonography.Diagnosis or reason for use: virtual colonoscopy via ct scan.

• Brand Name: AUTOMATED CO2 COLON INSUFFLATOR
• Type of Device: CT COLONOSCOPY INFUSSLATION DEVICE
• Manufacturer (Section D): BRACCO DIAGNOSTICS; monroe township NJ 08831
• MDR Report Key: 4824975
• MDR Text Key: 5910552
• Report Number: MW5042936
• Device Sequence Number: 1
• Product Code: FCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 390301
• Device Lot Number: 50865994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 87