MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC PROBE 5MM X 33CM, DISP FIXED; CATHETER IRRIGATION

Model Number	ASU1201
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information has been forwarded to the manufacturing facility for investigation.Results pending at this time a follow-up report will be submitted.
Event or Problem Description
Continuous suction without pressing the suction piston on the trumpet valve, the red control button didn't work.
Additional Manufacturer Narrative
No sample was received for evaluation therefore we are unable to confirm the issue reported.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.

• Brand Name: PROBE 5MM X 33CM, DISP FIXED
• Common Device Name: CATHETER IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 7562833
• Report Number: 1423537-2018-00208
• Device Sequence Number: 2527625
• Product Code: GBX
• UDI-Device Identifier: 10630140169700
• UDI-Public: 10630140169700
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: No Information
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 041722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/21/2018
• Patient Sequence Number: 1