MAUDE Adverse Event Report: E-Z-EM, INC. PROTOCOL ADMINISTRATION SET DELIVERY SYST. FOR COLON INSUFFLATION; PROTOCOL COLON INSUFFLATOR

Model Number 390309

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2018

Event Type  malfunction  

• Brand Name: PROTOCOL ADMINISTRATION SET DELIVERY SYST. FOR COLON INSUFFLATION
• Type of Device: PROTOCOL COLON INSUFFLATOR
• Manufacturer (Section D): E-Z-EM, INC.; 155 pinelawn road; suite 230n; melleville NY 11747
• Manufacturer Contact: patrice marchildon ; 155 pinelawn road, suite 230n; mellville, NY 11747 ; 5163333889
• MDR Report Key: 7764873
• Report Number: 2411512-2018-00005
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K030854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 390309
• Device Catalogue Number: 390309
• Device Lot Number: 60069616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1