MAUDE Adverse Event Report: LIEBEL FLARSHEIM ANGIOMAT ILLUMENA

Model Number ANGIOMAT ILLUMENA

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Customer stated no information was available on the tubing or the syringe other than the syringe was a malllinckrodt product (no product id or lot was provided).The problem was with the extension tubing slipping off of the syringe during use.Customer requested no service on the injector at this time, and had stated the problem had not occurred in the past week.If further information about the injector or the other products is provided additional reports will be opened as needed.

Event Description

During a procedure using mallinckrodt syringe (unknown product id) and tubing (brand unknown) the tubing became disconnected causing the contrast media to spray.No blood was in the syringe and the contrast did not hit anyone.Protocol was set at 20ml/sec with a rate rise of 0.2 at 900 psi.The reporter stated this has occured three times, but was unable to provide additional details or dates of the other events.No reported injury.

• Brand Name: ANGIOMAT ILLUMENA
• Type of Device: ILLUMENA
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4931569
• MDR Text Key: 22680710
• Report Number: 1518293-2015-00065
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGIOMAT ILLUMENA
• Device Catalogue Number: 900001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1